"Pharmaceutical Production Quality Management Specification (2010 Revision)"

(Ministry of Health Order No. 79)

Published on February 12, 2011

Ministry of Health of the People's Republic of China
                                                                        No. 79
           "The Pharmaceutical Production Quality Management Code (revised in 2010) has been approved by the Ministry of Health at the Ministry of Health, and is now issued, which is implemented from March 1, 2011.

                                                                                                                    Part minister:List old exhibit   Sputum surname
January 17, 2011

Chapter 1 General

Article 1 To standardize the quality management of drug production, this specification is formulated according to the "People's Republic of China Drug Administration Law\\

Article 2 Enterprises shall establish a pharmaceutical quality management system. The system should cover all factors affecting the quality of the drug, including ensuring that the quality of the drug is in line with the organizational and planned activities.

Compliance with the predetermined use and the required drugs.

Article 4 Enterprises shall strictly implement this norm, adhere to honesty and trustworthiness, prohibit any false, deception.

Chapter 2 Quality Management

First section

Ensure that the drug produced is in line with the predetermined use and registration requirements.

Article 6 Enterprise executives shall ensure that established quality objectives, different levels of personnel and suppliers, and dealers should participate in and bear their respective responsibilities.

Article 7 The enterprise shall be equipped with sufficient personnel, factory buildings, facilities and equipment, providing the necessary conditions for realizing quality objectives.

Second Quality Assurance

Article 8 Quality Assurance is part of the quality management system. Companies must establish a quality assurance system while establishing a complete file system to ensure that the system is effective.

Article 9 Quality Assurance System Should ensure:
(1) Design and research and development of drugs reflect the requirements of this specification;
(2) Production management and quality control activities in accordance with this specification;
(3) Management responsibilities are clear;
(4) The raw materials and packaging materials purchased and used are correct;
(5) The intermediate product is effectively controlled;
(6) Confirmation, verification implementation;
(7) Strictly follow the procedures for production, inspection, inspection and review;
(8) Each batch of products can be released after approval by quality controller;
(9) There is a proper measure of the quality of drug quality during storage, shipping, and subsequent operations;
(10) In accordance with the self-test operating procedures, regular inspection of the effectiveness and applicability of the assessment quality assurance system.

Article 10 Basic requirements for the quality management of pharmaceutical production:
(1) Develop production processes, systematically review and demonstrate their sustainable and stable products that meet the requirements;
(2) The production process and its significant changes are verified;
(3) Equipped with the resources required, at least include:
1. With proper qualifications and qualified personnel;
2. Sufficient factory and space;
3. Applicable equipment and maintenance guarantees;
4. Correct raw materials, packaging materials and labels;
5. Approved process procedures and operating procedures;
6. Appropriate storage conditions.
(4) Establishing actions should be used to use accurate and easy-to-understand language;
(5) Operators can be trained to operate correctly according to the operation procedures;
(6) The whole process of production should be recorded, and the deviation has been investigated and recorded;
(7) Batch records and shipping records should be able to trace the complete history of batch products, and keep it properly, which is convenient to consult;
(8) Reduce quality risks during the process of drug delivery;
(9) Establish a drug recall system to ensure that any group of products that have been shipped;
(10) The investigation leads to the causes of drug complaints and quality defects, and takes measures to prevent similar quality defects from occurring again.

Section 3 Quality Control

Article 11 Quality Control includes corresponding organizational institutions, document systems, and sampling, inspection, etc., ensuring that materials or products complete the necessary inspections before release, and confirm their quality meets the requirements.

Article 12 Basic requirements for quality control:
(1) It should be equipped with appropriate facilities, equipment, instruments, and trained personnel, effective, reliably completing relevant activities of all quality control;
(2) The operating procedures should be approved, used for the sample, inspection, inspection, and product stability inspection, inspection, inspection, and product stability inspection, inspection, inspection, and product to be packaged, and to ensure that it is in line with this specification. Requirements;
(3) Sampling of the original accessories, packaging materials, intermediate products, and finished products by authorized personnel according to the prescribed method;
(4) The inspection method should be verified or confirmed;
(5) Sampling, inspection, inspection should be recorded, and the deviation should be investigated and recorded;
(6) Materials, intermediate products, and finished products must be inspected and inspected according to quality standards, and have records;
(7) The finished product of materials and final packaging should have sufficient amount of prohibited, with the necessary inspection or test; except for the final packaging container excessive finished product, the finished product poster should be the same as the final package.

Section 4 Quality Risk Management

Article 13 Quality Risk Management is a systematic process for assessing, controlling, communication, and review quality risks in the entire product life cycle.

Article 14 The quality risk shall be evaluated according to scientific knowledge and experience to ensure product quality.

Article 15 The methods, measures, forms and formation forms used in the quality risk management process should be adapted to the level of risk.

Chapter III Agency and Personnel

First section

Article 16 Enterprises shall establish a management institution that is adapted to the production of drugs and has an organizational institution.
Enterprises should establish an independent quality management department to perform the responsibilities of quality assurance and quality control. The quality management department can set up quality assurance sectors and quality control sectors.

Article 17 The quality management department shall participate in all quality-related activities, responsible for reviewing all documents related to this specification. Quality management department personnel shall not entrust responsibilities to personnel from other departments.

Article 18 If an enterprise shall be equipped with a sufficient number of management and operators with appropriate qualifications (including academic qualifications, training and practical experience), and the responsibilities of each department and each post should be clearly stated. The job responsibilities must not be missing, and the crosses should be clearly stated. The responsibilities assumed by each person should not be too much.
All personnel should clearly understand their duties, familiar with their duties, and accept the necessary training, including training and continuing training.

Article 19 The duties are usually not entrusted to others. If you need to be commissioned, your duties can entrust them to a particularly qualified designated person.

Second section Key personnel

Article 20 Keyperes should be a full-time staff of the enterprise, at least include the company's person in charge, the person in charge of the production management, the quality management person in charge, and the quality controller.
The person in charge of quality management and the person in charge of the production management shall not be part of each other. Quality management person in charge and quality can be part of it. Operation procedures should be formulated to ensure that quality is independent of independence, and is not interfered by corporate leaders and other personnel.

Article 21
The person in charge of the enterprise is the main responsible person of the quality of the drug, and is responsible for the daily management of the company. In order to ensure that the company's quality goals and requires production drugs in accordance with this specification, the person in charge of the enterprise shall be responsible for providing the necessary resources, rational plans, organizations and coordination to ensure the quality management department independently fulfill their duties.

Article 22
(1) Qualification:
The person in charge of the production management should have at least a pharmaceutically or related professional undergraduate degree (or the eligibility of the intermediate professional technical title or the qualification of the pharmacist), with a practical experience of at least three years of practical experience in drug production and quality management, which at least one year of drug production management experience, acceptance Through expertise related to the produced product.
(2) Main responsibilities:
1. Ensure that drugs are produced, stored in accordance with the approval process, to ensure the quality of drugs;
2. Ensure that various operating procedures related to production operations are strictly enforced;
3. Make sure the batch production records and batch packaging records have been reviewed and sent to quality management departments.
4. Make sure the maintenance of the plant and equipment to maintain its well-operated state;
5. Ensure a variety of necessary verification work;
6. Ensure that the manufacturer is necessary for the necessary job training and continuing training, and adjusts the training content according to the actual needs.

Article 23 Lead of Quality Management
(1) Qualification:
The person in charge of the quality management should have at least a pharmaceutically or related professional undergraduate degree (or the eligibility of the intermediate professional technical title or the qualification of the pharmacist). It has the practice experience of at least five years of practical experience in drug production and quality management, of which at least one year of drug quality management experience, acceptance Through expertise related to the produced product.
(2) Main responsibilities:
1. Ensure that raw materials, packaging materials, intermediate products, to be packaged products and finished products in accordance with registered approval requirements and quality standards;
2. Make sure to complete the review of batch records before the product is released;
3. Make sure all necessary inspections are completed;
4. Approval quality standards, sampling methods, test methods, and other quality management operation procedures;
5. Audit and ratify all relevant changes in quality;
6. Make sure all major deviations and test results exceed the standard have been investigated and processed in time;
7. Approve and supervise the entrustment inspection;
8. Supervise the maintenance of plant and equipment to maintain its well-running state;
9. Make sure to complete a variety of necessary confirmation or verification, review, and approve confirmation or verification schemes and reports;
10. Ensure self-test;
11. Assess and approve material suppliers;
12. Ensure that all complaints related to product quality have been investigated and get timely, correct treatment;
13. Ensure the continuous stability of the product to provide stability inspections;
14. Ensure that the product quality review is completed;
15. Ensure that quality control and quality assurance personnel have been necessary to train and continue training, and adjust the training content according to actual needs.

Article 24 The person in charge of the production management and quality management usually has the following common responsibilities:
(1) Audit and approve the process procedures, operational procedures such as products;
(2) Supervision plant health status;
(3) Ensuring that key equipment is confirmed;
(4) Ensuring the production process verification;
(5) Ensuring that all relevant personnel of the enterprise have been necessary to train and continue training, and adjust the training content according to actual needs;
(6) Approve and supervise the entrusted production;
(7) Determine and monitor the storage conditions of materials and products;
(8) Save record;
(9) Supervise the implementation of this specification;
(10) Monitoring factors affecting product quality.

Article 25
(1) Qualification:
Quality is subject to at least a pharmaceutically or related professional undergraduate degree (or intermediate professional technical title or qualification for pharmacist), with a practical experience of at least five years of practical experience in drug production and quality management, engaged in drug production process control and quality inspection.
Quality is subject to the necessary professional theoretical knowledge, and through training related to the product, it can perform its duties independently.
(2) Main responsibilities:
1. Participate in the establishment of enterprise quality system, internal self-test, external quality audit, verification, and drug adverse reactions, product recall and other quality management activities;
2. Take the responsibility of the product release, to ensure that the production and inspection of each batch has been in line with relevant regulations, drug registration requirements and quality standards;
3. Before the product is released, the quality is required to issue a product in accordance with the requirements of the second item described above, and incorporate a batch record.

Section 3 training

Article 26 If an enterprise shall designate a department or a special person responsible for training management, and the training program or plan shall be preserved with training programs or programs for reviewing or approved by the person in charge of the production management or quality management.

Article 27 All personnel related to drug production and quality shall be trained, and the content of the training should be adapted to the requirements of the post. In addition to the training of this norm theory and practice, there should also be relevant regulations, the responsibilities, skills of corresponding positions, and regular assessment of the actual effects of training.

Article 28 The staff of high-risk operating area (eg, high activity, high toxicity, infectious, high-sensitivity materials) should accept specialized training.

Section 4 people hygiene

Article 29 All personnel shall receive a training for health requirements, and companies should establish a personnel health operation procedure to minimize the risk of pollution to drug production.

Article 30 The health operating procedures shall include content related to health, health habits and personnel. Personnel in the production area and quality control area should correctly understand the relevant personnel health operation procedures. Enterprises should take measures to ensure the implementation of personnel health operation procedures.

Article 31 If an enterprise shall manage the health and establish a health profile. Health checks should be accepted before the production personnel who directly contact the drug should be accepted at least one health check.

Article 32 Enterprises shall take appropriate measures to avoid wounds, and those who have infectious diseases or other possible pollution drugs are engaged in direct contact with drugs.

Article 33 If a visit personnel and unhaded persons shall not enter the production area and quality control zone, and special circumstances must be entered, and personal hygiene, clothes, etc. should be guided in advance.

Article 34 Anyone who enters the production area shall be smashed in accordance with the regulations. Workwearing, model, and wear methods should be adapted to the work and air cleanliness levels of the air.

Article 35 If a person entering a clean production area shall not make makeup and wear an ornaments.

Article 36 Production Zone, the warehouse should ban smoking and diet, prohibit non-production items such as food, beverage, cigarettes and personal medicines.

Article 37 The operator should avoid direct contact with the drug directly to the packaging materials and equipment surfaces directly in contact with the drug.

Chapter IV Factory and Facilities

First section

Article 38 The location, design, layout, construction, transformation and maintenance of the factory must meet the requirements of drug production, and should be able to maximize pollution, cross-contamination, confusion and errors, easy to clean, operate, and maintenance.

Article 39 shall consider the location according to the planting and production of protective measures, the environment in which the plant is located should be able to minimize the risk of contamination of materials or products.

People within, logistics goal should be reasonable.

Article 41 shall be properly maintained for the plant, and ensure that the maintenance activities do not affect the quality of the drug. The plant should be cleaned or necessary to disinfection in detailed written operation procedures.

Article 42 The plant should have appropriate lighting, temperature, humidity, and ventilation to ensure that the quality of the product and storage is not directly or indirectly affected directly or indirectly.

Article 43 The design and installation of a factory, facilities should be able to effectively prevent insects or other animals. The necessary measures should be taken to avoid contamination of equipment, materials, and products used in the utensils, insecticides, and smoked agents used.

Article 44 shall take appropriate measures to prevent unauthorized entry. Production, storage, and quality control areas should not be used as direct channels of non-introspect staff.

Article 45 The completion drawings after the construction or transformation of the factory, public facilities, fixed pipeline should be preserved.

Second Production Area

Article 46 In order to reduce the risk of pollution and cross-contamination, plant, production facilities and equipment should be reasonably designed, layout and use according to the characteristics, process flow and corresponding cleanliness levels of the drug, and meet the following requirements:
(1) Comprehensively consider factors such as the characteristics, process and scheduled use of drugs, and determine the feasibility of multi-product sharing of plant, production facilities and equipment, and have corresponding assessment reports;
(II) Production of special nature, such as high-sensitive drugs such as penicillin or biological products such as cardians or other drugs prepared by other active microorganisms, special and independent plant, production facilities and equipment must be used. The operating area of penicillin drugs should maintain a relatively negative pressure, and the exhaust gas to the outdoor should be purified and meet the requirements, and the exhaust port should be away from other air purification systems;
(3) Production of beta-lactam structural drugs, sex hormone contraceptive drugs must use special facilities (such as independent air purification systems) and equipment, and strictly separate from other drug production zones;
(4) Producing certain hormones, cytotoxicity, highly active chemicals should use specialized facilities (such as independent air purification systems) and equipment; in special cases, such as special protective measures and necessary verification, the above pharmaceutical preparation The same production facilities and equipment can be shared by phased production methods;
(5) The air purification system used in the above paragraph (2), (3), and (4), and the exhausting should be purified;
(6) Pharmaceutical production plant shall not be used to produce non-pharmaceutical products that have adversely affected drug quality.

Overlook or error occurs.

Article 48 shall, according to the drug variety, production operation requirements and external environment conditions, the air conditioning purification system is configured to effectively ventilate, and there is temperature, humidity control and air purification filtration, and ensure that the production environment of the drug meets the requirements.
Between the clean zone and the non-cleaning zone, the pressure difference between different levels of clean zone should not be less than 10 Pasca. If necessary, the appropriate differential degree gradient should also be maintained between the different functional areas (operation) of the same cleanliness level.
Oral Liquid and solid preparation, cavity drug (containing columns) The requirements for the D-Class D Cleaning Area in the appendix are set to take appropriate microbiological monitoring measures to this area according to the standards and features of the product.

Article 49 The inner surface of the clean area (wall, ground, heavens) should be smooth, no cracks, strict interfaces, no particulate matter fall off, avoid dust, easy to clean, if necessary, should be disinfected.

Article 50 The design and installation of various pipelines, lighting facilities, wind, and other public facilities should avoid uncommitted parts, and should be maintained outside the production area as much as possible.

Article 51 The drainage facilities should be sized, and the device to prevent inverting is installed. It should be avoided as much as possible; if you are inevitable, the Ming Du is shallow to facilitate cleaning and disinfection.

Article 52 The raw material weighing of formulations is usually carried out within a specialized weighing chamber.

Article 53 During production of dust (such as dry materials or product samples, weighs, mixing, packaging, etc.) should maintain relative negative pressure or special measures to prevent dust spread, avoid cross-contamination and easy cleaning.

Article 54 The factory or region for drug packaging should be reasonably designed and layout to avoid confusion or cross-pollution. There are several packaging lines in the same area, and there should be quarantine measures.

Article 55 The production area shall have a moderate lighting, and the lighting of the visual operation area shall meet the operational requirements.

Article 56 The intermediate control area can be set in the production area, but the intermediate control operation shall not bring quality risks to the drug.

Third quotation

Article 57 The storage area should have enough space to ensure orderly storage, qualified, unqualified, returned, return or recall of raw materials, packaging materials, intermediate products, waiting for products and products for packaging products and finished products.

Article 58 The design and construction of the warehouse should ensure a good warehouse condition and have ventilation and lighting facilities. The warehouse area should be able to meet the storage conditions of materials or products (such as temperature and humidity, exposure) and safe storage, and inspect and monitor.

Article 59 Highly active materials or products, and printing packaging materials should be stored in a safe area.

Article 60, receives, distribution, and shipping areas should be able to protect the material, product is affected by the external weather (such as rain, snow). The layout and facility of the receiving area should be able to ensure that the goods can be easily cleaned to the outer packaging before entering the warehousing area.

Article 61 If a separate isolation area is stored in a separate isolation area, the abuting area should have a striking identification and is limited to the approved person.
Unqualified, returned or recalled materials should be stored.
This method should have equal security if other methods are backed by physical isolation.

Article 62 The usually there should be a separate material sampling area. The air cleanliness level of the sampling area should be consistent with the production requirements. If you are sampling in other regions or otherwise, pollution or cross-contamination should be prevented.

Section 4 Quality Control Area

Article 63 The quality control laboratory usually should be separated from the production area. The laboratory of biological assays, microorganisms and radioisotopes should also be separated from each other.

Article 64 The design of the laboratory should ensure that it is suitable for a predetermined purpose and can avoid confusion and cross-contamination, and there should be sufficient area for sample disposal, stamp and stability to investigate the storage of samples and the storage of records.

Article 65 If necessary, a specialized instrument room should be set to disturb the sensitivity of instruments from static, vibration, moist or other external factors.

Article 66 The laboratory of special items such as biological samples or radioactive samples shall comply with the relevant national requirements.

Article 67 The experimental animal room shall be strictly separated from other regions, and its design should comply with relevant national regulations, and a separate air treatment facility and an animal-specific channel.

Section 5 Auxiliary Area

Article 68 The settings of the lounge shall not have adverse effects on the production area, the warehousing area and the quality control zone.

Article 69 The locker room and the washroom should be convenient for personnel to enter and exit, and adapt to the number of users. The washroom must not communicate directly with the production area and the warehouse area.

Article 7 The repair between repairs should be as far as possible from the production area. Store spare parts and tools stored in clean zones, should be placed in a dedicated room or tool cabinet.

Chapter 5 Equipment

First section

Disinfect or sterilize.

Article 72: Operation procedures for use, clean, maintenance, and maintenance should be established, and the corresponding operation records are stored.

Article 73 shall establish and save equipment procurement, installation, confirmation documents and records.

Second section design and installation

Article 74 The production equipment shall not have any adverse effects on the quality of the drug. The surface of the production equipment directly in contact with the drug should be flat, smooth, easy to clean or disinfect, corrosion resistant, and may not be chemically reacted with the drug, adsorb the drug or release the substance into the drug.

Article 75 shall be equipped with an appropriate range and accuracy weighing instrument, measuring instrument, instrument and instrument.

Article 76 The appropriate cleaning, cleaning equipment should be selected, and prevent such equipment from being polluted sources.

Article 77 If the lubricant used in the equipment, coolants such as coolants may not cause contamination to drugs or containers, which should be used as much as possible to use a lubricant equivalent as possible.

Article 78 The procurement, acceptance, storage, maintenance, distribution and scrapping of the production mold shall formulate the appropriate operational procedures, and set up a special person counters, and have corresponding records.

Section III Maintenance and Maintenance

Article 79 The maintenance and maintenance of equipment shall not affect product quality.

Article 80 shall formulate a preventive maintenance plan and operating procedure for equipment, and the maintenance and maintenance of the equipment shall have corresponding records.

Article 81 The equipment that has been transformed or significant maintenance should be reconfirmed and can be used in accordance with the requirements.

Section 4 use and clean

Article 82 The main production and inspection equipment shall have a clear operating procedure.

Article 83 The production equipment shall be used within the confirmed parameter range.

Article 84 shall clean the production equipment in accordance with the detailed manner.
Production equipment cleaning procedures should specify specific and complete cleaning methods, cleaning equipment or tools, cleaner names and formulation methods to remove the previous batch of identified methods, protecting the cleaning equipment is avoiding pollution before use , The longest saving time limit of the device has been cleaned, and the method of checking the device is checked, so that the operator can clean all kinds of equipment in reusable, effective way.
If you need to disassemble the equipment, the sequence and method of equipment disassembly should also be specified; if you need to disasse or sterilize equipment, the specific method of disinfection or sterilization should also be specified, the name and formulation of disinfectants. If necessary, it should also be specified to end the maximum intervals permitted by the equipment production until clean before cleaning.

Article 85 The cleaned production equipment shall be stored under clean and dry conditions.

Article 86 Equipment and instruments used in drug production or inspection shall have a log, and the recordings include the use, clean, maintenance and maintenance of the drug name, specification and batch number, etc., time, production and test.

Article 87 The production equipment should have a clear status identification, indicating the device number and content (such as name, specifications, batch number); there is no contents of the content.

Article 88 Unqualified equipment If it is possible to carry out the production and quality control zone, there should be a striking status identification before being moved out.

Article 89 The main fixed pipeline shall indicate the content name and flow direction.

Section 5

Article 9: Calibration and inspection of production and inspection instruments, measuring instruments, meters, records, and control equipment, and instruments should be calibrated and inspected in accordance with the operating procedures and calibration plans, and the relevant records are saved. The scope of the calibration should cover the range of use of actual production and inspection.

Article 91 The key meter, measuring instrument, record, and control equipment, and instruments are calibrated, and the resulting data is accurate and reliable.

Article 92: The measurement standard appliance should be used to calibrate, and the measurement standard appliances used should comply with relevant national regulations. The calibration record should indicate the name, number, calibration validity period, and measurement number of the measurement standard appliances used to ensure the traceability of the record.

Article 93 Weighing instruments, measuring instruments, equipment for recording and control, and instruments should have obvious identifiers, indicating that their calibration is valid.

Article 94 shall not use unclear, exceeding the calibration validity period, an immersion device, measuring instrument, and equipment for recording and controlling, and instruments.

Article 95 In the production, packaging and storage of automatic or electronic devices, the calibration and inspection shall be performed in accordance with the operating procedures to ensure that their operation is functioning. Calibration and inspection should have corresponding records.

Section 6 Pharmaceutical Water

Article 96 The pharmaceutical water should be suitable for its use and comply with the quality standards and related requirements of the Pharmacopoeia of the People's Republic of China. The pharmaceutical water should at least use drinking water.

Article 97 The design, installation, operation and maintenance of water treatment equipment and its conveying system shall ensure that pharmaceutical water reaches the set quality standards. The operation of the water treatment equipment must not exceed its design capabilities.

Blind tube.

Article 99 Purification water, preparation, storage and distribution of water injection should be capable of preventing the growth of microorganisms. Purification water can be circulated, and water for injection can be used in 70° CThe above incubation cycle.

Article 100 shall perform regular monitoring of water quality of pharmaceutical water and raw water, and have corresponding records.

Article 101: Purification water and injection water pipes should be cleaned according to the operation procedure, and there is a related record. It has been found that pharmaceutically acceptable water microbial contamination reaches a warning limit, and the correction shall be processed in accordance with the operation procedure.

Chapter 6 Materials \\u0026 Products

First section

The raw materials used in Article 102 Drug production should comply with the corresponding quality standards. The ink used in the pharmaceutical direct printing should meet the requirements of edible standards.
Imported raw materials should comply with national related import management regulations.

Article 103 The operational procedures for materials and products should be established to ensure proper reception, storage, distribution, use and shipping of materials and products, prevent pollution, cross-pollution, confusion and errors.
The processing of materials and products should be implemented in accordance with operating procedures or process procedures, and have records.

Article 104 The determination and change of material suppliers shall be quality assessment and can be purchased after approval by the quality management department.

Article 105 Materials and product transport should be able to meet the requirements of its guarantee quality, and there is special requirements for transportation, and its transportation conditions should be confirmed.

.
The outer packaging of materials should have labels and indicate the specified information. If necessary, clean, discovery of external packaging damage or other issues that may affect material quality should be reported to the quality management department and investigated and recorded.
There should be records each reception, including:
(1) The name of the material noted on the delivery form and the packaging container;
(2) Material name and (or) code used interior;
(3) Receive date;
(4) Name of suppliers and producers (such as different);
(5) Number of suppliers and producers (such as different) logo;
(6) Number of receiving the total amount and packaging containers;
(7) Receive the batch number or water number designated by the enterprise;
(8) The instructions (such as packaging status).

Article 107 After the material receives and finished product production, it shall be managed in time until it is released.

Article 108 Materials and products shall be based on their nature ordered batch storage and turnover, and the delivery shall comply with the principle of advanced first out and the advanced period.

Article 109 Use computerized warehouse management, should have corresponding operational procedures to prevent confusion and errors from materials and products due to special circumstances such as system failure, shutdown.
Relevant information such as materials, products, etc. are identified using a fully computerized warehouse management system, and it is not necessary to indicate in writing.

Second section original accessories

Article 110 shall formulate appropriate operational procedures, take appropriate measures such as check or inspection, confirm that the original film in each packaging is correct.

Article 111 If you receive a batch of materials at a time, you should check and release it according to the batch.

Artvit materials in the 1122 warehousing should have appropriate logos and at least indicate the following:
(1) The designated material name and material code interior;
(2) The batch number set when the enterprise receives;
(3) Material quality (such as premature, qualified, unqualified, sampled);
(4) Validity or review period.

Article 1 Thirteen is only approved by the quality management department and can be used in the validity or the original auxium in the validity period or the re-test period.

Article 114 The raw material shall be stored in accordance with the validity period or a review period. During the storage period, if you find a special case of adverse effects on the quality, you should check it.

Article 115 shall be blended according to the operating procedures, and then accurately weigh or measure, and logo it.

Article 116 The material and weight or volume of the formulation should be reviewed independently of others and review.

Article 117 If all ingredients for the same batch of drugs should be concentrated, and logo it.

Section III Intermediate Products and Waiting Products

Article 118 Intermediate products and to be packaged products should be stored under appropriate conditions.

Article 119 Intermediate products and the product to be packaged should have a clear identification and at least indicate the following:
(1) Product name and product code interior in the enterprise;
(2) Product batch number;
(3) Quantity or weight (such as gross weight, net weight, etc.);
(4) Production process (if necessary);
(5) Product quality status (if necessary, if you are premature, qualified, unqualified, sampled).

Section 4 packaging materials

Article 120 The management and control requirements of packaging materials and printed packaging materials directly in contact with drugs are the same as those of the raw materials.

Article 121 packaging materials shall be issued by a special person according to the operating procedures and take measures to avoid confusion and errors to ensure that packaging materials used in drug production are correct.

The original version of the packaging material.

Article 123 When the version of the printing packaging material should be taken, measures should be taken to ensure that the version of the printing packaging material used in the product is correct. It is advisable to recover the old version of the print template and destroy it.

Article 124 The print packaging materials should be set up in a special area to be properly stored, and it is not allowed to enter without approval. Cutting labels or other bulk print packaging materials should be placed in a sealed container to prevent confusion.

Article 255 The printing packaging material shall be kept by a special person and is issued in accordance with the operation procedures and demand.

Article 126 Each batch or a packaging material or printing packaging material that is directly contacted with drugs shall be identified, indicating the name and batch number of the product used.

Article 27 When expired or discarded print packaging materials shall be destroyed and recorded.

Section 5

Article 128 should be stored before the finished product is released.

Article 129 The storage conditions of finished products shall comply with the requirements of drug registration approval.

Section 6 Special Management Materials and Products

Relevant provisions.

Seventh section

Article 131 Unqualified materials, intermediate products, each packaging container for the package to be packaged products and finished products should have a clear and striking sign and store it in the isolation zone.

Article 132 Unqualified materials, intermediate products, treatment of products to be packaged products and finished products shall be approved by the person in charge of quality management and record.

Article 133 Product recycling needs to be pre-approved and fully evaluated the relevant quality risks, and decides whether to recycle according to the assessment conclusion. The recycling should be carried out in accordance with a predetermined operating procedure and have a corresponding record. The product after recycling should be determined in accordance with the initial production date of the first batch product in the recovery process.

Article 134 formulation products shall not be re-process. Unqualified formulation intermediate products, to be packaged products and finished products. Rework processing is allowed only if it does not affect product quality, it meets the corresponding quality standards, and rework is allowed to be processed according to the predetermined, approved operational procedures and fully evaluate the relevant risks. Renewers should have corresponding records.

Article 135 Finished products produced by rework or re-processing or recovery, the quality management department shall consider the inspection and stability of additional related projects.

Article 136 If an enterprise shall establish a procedure for the drug returns, there is a corresponding record, and the content should include: product name, batch number, specification, quantity, return unit and address, return cause and date, ultimately handled opinion.
The return of the same product of the same batch of different channels should be recorded, stored, and processed separately.

Article 137 If there is an inspection, inspection and investigation, there is evidence that the return quality is not affected, and after evaluation by the quality management department, the return will be re-packaged and re-shipped. The factors that the evaluation consideration should include at least the nature of the drug, the required storage conditions, the current situation, history, and interval between shipping and returns. If the return of storage and transportation requirements should be destroyed under the supervision of the quality management department. If you have doubts about the quality of the return, you must not ship it.
For returns to return, the recycled product should meet the predetermined quality standards and article 133 requirements.
The process and results of the return treatment should have corresponding records.

Chapter 7 Confirmation and Verification

Article 138 Enterprises shall determine the need to confirm or verify, to prove that the key elements of the operation can be effectively controlled. The scope and extent of confirmation or verification should be determined by a risk assessment.

Article 139 Enterprise's factory buildings, facilities, equipment, and inspection instruments shall be confirmed that production, operation and testing should be carried out using a verified production process, operating procedures, and test methods, and maintain a continuous verification state.

Article 140 The documents and records that confirm and verification should be established, and can prove the following objects with files and records:
(1) Design confirmation should prove that the plant, facilities, equipment design meets the requirements of the scheduled use and this specification;
(2) Installation and confirmation should prove the construction and installation of plant, facilities, equipment, in accordance with design standards;
(3) Operation and confirmation should prove the operation of plant, facilities and equipment in accordance with design standards;
(4) Performance confirmation should prove that the plant, facilities, and equipment can continue to meet the standards under normal operation methods and process conditions;
(5) Process verification should prove that a production process can continue to produce products that meet the requirements and registration requirements according to the prescribed process parameters.

Article 141 The applicability of routine production should be verified before the new production prescription or production process. The production process should always produce products that meet the predetermined use and registration requirements under the use of the specified raw materials and equipment conditions.

Or verify. If necessary, it should also be approved by the drug supervision and management department.

Article 143 Cleaning methods shall be verified to confirm its cleaning effect to effectively prevent pollution and cross-contamination. Cleaning verification should consider the use of equipment, the cleaner and disinfectant, sampling method and position and the corresponding sampling recovery rate, the properties of the residue, and the sensitivity of the residue test method.

Article 144 Confirmation and verification is not a one-time behavior. After the first confirmation or verification, it should be confirmed or reproduced according to the product quality review analysis. The key production process and operating procedures shall be verified regularly to ensure that it can achieve the expected results.

Article 145 Enterprises shall formulate a validation plan to illustrate key information to confirm with the verification work in a file form.

Article 146 The verification plan or other relevant documents shall be made to ensure that the plant, facilities, equipment, inspection instruments, production processes, operation procedures, and test methods can remain sustained to stabilize.

Article 147 shall develop a confirmation or verification scheme based on the object of confirmation or verification, and reviewed and approved. Confirmation or verification plan should be clearly responsible.

Article 148 Confirmation or verification shall be implemented in accordance with predetermined and approved schemes. After confirming or verifying, the report should be written and reviewed and approved. The results and conclusions of confirmation or verification (including evaluation and suggestions) should be recorded and archived.

Article 149 shall confirm the process procedures and operating procedures based on the results of the verification.

Chapter 8 File Management

First section

Article 150 The document is the basic element of the quality assurance system. Enterprises must have correct written quality standards, production prescriptions and process procedures, operational procedures, and documents.

Article 151 If an enterprise shall establish a document management's operating procedure, systematically design, formulate, review, approval, and distribute documents. Documents related to this specification should be reviewed by the quality management department.

Article 152 The content of the document shall be consistent with relevant drug production licenses, drug registration, and other related requirements, and help to trace the history of each batch of products.

Article 153 The drafting, revision, review, approval, replacement or revocation, replication, storage and destruction of documents shall be managed in accordance with the operation procedures, and have the corresponding document distribution, revoking, copying, and destruction records.

Article 154 The drafting, revision, review, and approval of the document shall be signed by the appropriate personnel and indicate the date.

Article 155 These documents shall indicate the topic, type, purpose, and document number and version number. Text should be exact, clear, easy to understand, and cannot be ambiguous.

Article 156 The document shall be classified, and it is easy to check.

Article 157 When the original document is copied, no error should be generated; the copied file should be clearly identified.

Article 158 The document shall be reviewed, revised; after the documentation is revised, the old version of the document should be prevented from being misused. Distribution, the files used should be approved for the current text, withdrawn or older files, and must not appear on the work site.

Article 159 The activities related to this specification shall be recorded to ensure product production, quality control and quality assurance. Record should leave sufficient spaces for filling in data. The record should be filled in in time, the content is true, the writing is clear, easy to read, not easy to erase.

Article 160 should be used as much as possible to use a record, map, and graphs, etc. of the production and inspection equipment, and indicate the name of the product or sample, the batch number, and record equipment, the operator should endorse the name and date.

Article 161 Records should be kept clean, and must not tear and arbitrarily altecate. Any changes filled in filled with the name and date, and the original information is still clear, if necessary, the reasons for changes should be explained. If the record is re-written, the original record shall not be destroyed, and should be saved as an attachment of the recording.

Article 162 Each drug should be batch records, including batch production records, batch packaging records, batch inspection records, and drug release audit records, etc. related to this batch product. The batch record shall be managed by the quality management department, and at least one year after the drug is valid.
Quality standards, process procedures, operational procedures, stability investigations, confirmation, verification, and change, etc. should be saved for a long time.

Article 163 If you use an electronic data processing system, a photographic technology or other reliable way to record data data, the system's operating procedures should be used; the accuracy of records should be checked.
With electronic data processing systems, only authorized person can enter or change data, change, and delete the situation should be recorded; the password or other means should be used to control the system's login; after the key data is entered, it should be independently reviewed independently. .
Batch records saved by electronic methods should be backed up by tape, microfilters, paper copies, or other methods to ensure the safety of records, and data data is convenient during storage.

Second section quality standard

Article 164 Materials and finished products shall have an approved current quality standards; if necessary, the middle product or the product to be packaged should also have quality standards.

Article 165 Material quality standards should generally include:
(1) Basic information about materials:
1. Enterprise unified designated material name and internal material code;
2. The basis for quality standards;
3. Approved suppliers;
4. Samples of print packaging materials.
(2) Sampling, inspection method, or related operating procedure number;
(3) Limited requirements for qualitative and quantitative;
(4) Storage conditions and precautions;
(5) Validity or review period.

.

Article 167 The quality standards of finished products shall include:
(1) Product name and product code;
(2) Corresponding product prescription number (if any);
(3) Product specifications and packaging forms;
(4) Sampling, inspection method, or related operating procedures number;
(5) Limited requirements for qualitative and quantitative;
(6) Storage conditions and precautions;
(7) Validity period.

Section 3 Process Regulations

Article 168 Every production batch of each drug shall have a process procedure approved by the enterprise, and each packaging form of different drug specifications shall have their own packaging operation requirements. The development of process procedures shall be based on the process of registration approval.

Article 169 Process procedures shall not be arbitrarily changed. If you need to change, you should be revised, reviewed, approved, reviewed.

The content of the process procedures for the 170th formulation should include:
(1) Production prescription:
1. Product name and product code;
2. Product dosage form, specifications and batch;
3. The original accessories used (including the use of the production process, but the materials that appear in the finished product), clarify the specified name, code and amount of each material; if the amount of the original accessories need to be converted, the calculation method should also be described.
(2) Production operation requirements:
1. Description of the production site and the equipment used (such as the position and number, cleanliness level, the necessary temperature and humidity requirements, equipment model and number, etc.);
2. Preparation of key devices (such as cleaning, assembly, calibration, sterilization, etc.), or corresponding operating procedures number;
3. Detailed production steps and process parameters (such as check, pretreatment, order of materials, mixing time, temperature, etc.);
4. All intermediate control methods and standards;
5. Expected final production limits, if necessary, the production limit of the intermediate product, and the calculation method and limit of material balance;
6. Storage requirements for the product to be packaged, including containers, labels and special storage conditions;
7. Precautions that need to be explained.
(3) Packaging operation requirements:
1. Packaging form representation, weight or volume expressed in the final packaging container;
2. The full list of all packaging materials, including the name, quantity, specifications, type, and code related to the quality standards;
3. Print the sample or replica of the packaging material, and indicate the product batch number, the validity period is printed;
4. Precautions need to be explained, including inspections for production area and equipment, before the package operation begins, the clearance of the package production line has been completed;
5. Description of the packaging operation steps, including important auxiliary operations and precautions for the equipment used, and check before the use of packaging materials;
6. Detailed operation of intermediate control, including sampling methods and standards;
7. Better balance calculation method and limit of materials to be packaged products, printing packaging materials.

Section 4 Batch Production Record

Article 171 Each batch of products shall have corresponding batch production records, which can be traced back to the production history of the product and related to quality.

Article 172 Batch production record shall be developed according to the relevant content of the currently approved process procedure. The recorded design should avoid filling in an error. Each of the batch records should be marked with the name, specification and batch number of the product.

Article 173 The original blank batch record shall be reviewed and approved by the person in charge of the production management person in charge and quality management. Batch production records should be controlled and recorded in accordance with the operating procedures. Each batch of products can only issue a copy of the original blank batch record.

Article 174 In the production process, it should be recorded in time when performing each operation, and after the operation is completed, it shall be confirmed and endorse the name and date by the production operator.

Article 175 The content of the production record should include:
(1) Product name, specification, batch number
(2) The date and time of production and intermediate processes, end;
(3) Signature of the person in charge of each production process;
(4) Production Steps The signature of the operator; if necessary, there should be an operation (such as weigh) the checkpoint of review;
(5) The batch number of each original excipient and the actual weighted quantity (including the batch number and quantity of the renewal or rework processing);
(6) Related production operations or activities, process parameters and control range, and number used in the main production equipment;
(7) Record of intermediate control and signature of the operator;
(8) The production process and the material balance calculation are calculated;
(9) Records of special problems or abnormal events, including detailed descriptions or investigation reports for deviation of deviations from the process procedures, and approved by signed.

Section 5 Batch Packaging Record

Article 176 The packaging of part of each product or some of the products per batch shall be batch packaging records to trace the product packaging operation and related quality.

Article 177 Batch packaging records shall be based on the content related to the packaging in accordance with the process regulations. The design of the record should be taken to avoid filling in an error. Each page of the packaging record should be marked with the name, specifications, packaging form and batch number of the packaged product.

Article 178 Batch packaging records shall be subject to the batch number, quantity of the product to be packaged, and the number of batch numbers and plans of the finished product. The original blank batch packaging record is the same as the original blank batches of production records.

Article 179 In the packaging process, it should be recorded in time, and after the operation is completed, the package should be confirmed and the name and date will be identified.

Article 180 Batch packaging records include:
(1) Product name, specification, packaging form, batch number, production date and validity period;
(2) The date and time of packaging operation;
(3) Signature of the person in charge of packaging operation;
(4) The operator signature of the packaging process;
(5) Name, batch number and actual use of each packaging material;
(6) Inspection records according to the process procedures, including intermediate control results;
(7) Details of packaging operations, including the number of equipment used and packaging production line;
(8) The sample used, and printed with batch number, validity period, and other print contents; it is not easy to package the printing material of the package recorded archive can adopt a replica with the above content;
(9) Records of special problems or abnormal events, including detailed descriptions or investigations reporting for deviations from the process procedures, and approved by signature;
(10) All print packaging materials and names, code, and distribution, use, destruction or reactive quantity, and material balance checks.

Section 6 Operation procedures and records

history.

Article 182 Factory, equipment, materials, documents, and records should be numbered (or code), and develop the operating procedures for the preparation number (or code) to ensure the uniqueness of the number (or code).

Article 183 The following activities should also have corresponding operating procedures, and their processes and results should be recorded:
(1) Confirmation and verification;
(2) assembly and calibration of equipment;
(3) Maintenance, cleaning and disinfection of plant and equipment;
(4) Training, closing and health, etc. related to personnel;
(5) Environmental monitoring;
(6) pest control;
(7) Change control;
(8) Deviation processing;
(9) Complaint;
(10) Drug recall;
(11) returned.

Chapter 9 Production Management

First section

Article 184 The production and packaging of all drugs shall be operated in accordance with the approval process procedures and operational procedures to ensure that drugs meet the requirements of the requirements and meet the requirements of drug production licenses and registration approval requirements.

Article 185 shall establish a procedure for dividing the product production batch, and the division of production batch shall ensure the uniformity of the same batch of product quality and characteristics.

Article 186 shall establish a compiled drug lot number and an operational procedure for determining the production date. Each batch of drugs should be prepared. In addition to another statutory requirement, the production date shall not be released later than the product formation or filling (seal) before the final mixing operation date, the product packaging date is not as the production date.

Article 187 Each product shall check the balance of production and material to ensure that the material balance meets the set limit. If there is a difference, the reason must be found, confirming that there is no potential quality risk, and can be treated according to normal product.

Article 188 shall not perform production operations of different varieties and specifications in the same production operation, unless there is no possibility of confusion or cross-contamination.

Article 189 In each stage of production, the products and materials should be protected from microorganisms and other pollutions.

Article 190 shall take special measures in the production of dry materials or products, especially high-activity, high toxic or high-sensitivity materials or products, and prevent the production and diffusion of dust.

If necessary, it should also be indicated in the production process.

Article 192 containers, devices or facilities should be clear, and the label format should be approved by the relevant authorities. In addition to using text instructions on the logo, different colors can also be used to distinguish the status of the identified (such as the premature, qualified, unqualified or cleaned).

Article 193 The product should be checked from a pipe from one area to another area to ensure that the connection is correct.

Article 194 After each production is over, it should be conducted to ensure that the equipment and workplace have no legacy of materials, products, and documents related to this production. Before the start of production, the previous Qingling situation should be confirmed.

Article 195 should avoid any deviation of any deviation of deviation from a procedure or operating procedure as possible. Once the deviation occurs, it should be performed in accordance with the deviation processing operation procedure.

Article 196 The production plant should be limited to the approval of personnel.

The second section prevents pollution and cross-contamination in the production process

Article 197 When the production process should take as measurement, pollution and cross-contamination, such as:
(1) Production of different varieties of pharmaceuticals in partitioned areas;
(2) Adopting stage production methods;
(3) Set the necessary gas latches and exhaust winds; the area different from the air cleanliness level should have differential pressure control;
(4) It should reduce the risk of unprocessed or unsuitable air to enter the production area to lead to pollution;
(5) In the production area that is easy to generate cross-contaminated, the operator should wear protective clothing dedicated to the region;
(6) Equipment cleaning is performed using verified or known valid cleaning and pollution operation procedures; if necessary, residues of the surface of the equipment directly in contact with the material should be detected;
(7) use a sealed system production;
(8) The air blowing of the drying equipment should have an air filter, and the exhausting should have an air backup device;
(Nine) The use of fragile, suspicion, and gentle meter should be avoided during production and cleaning; when using the screen, it should have measures to prevent pollution due to screen breakage;
(10) Preparation, filtration, potting, and sterilization of liquid preparations shall be completed within the specified time;
(11) Ointment, cream, gel and other semi-solid formulations and intermediate products of suppositories should specify storage period and storage conditions.

Article 198 The measures to prevent pollution and cross-contamination should be examined regularly and assess their applicability and effectiveness.

Section 3 production operation

Article 199 should be checked before the start of production, ensuring that the equipment and workplace have no more than a material, document or material that is not related to the production of this batch, and the equipment is cleaned and treated. The test results should be recorded.
Before the production operation, the name, code, batch number, and identification of the material or intermediate product should also be checked to ensure that the materials or intermediate products used in production are correct and meet the requirements.

Article 2 Articles shall perform intermediate control and necessary environmental monitoring and record it.

Each production period of each batch of drugs must be cleared by the production operator after each batch of pharmaceuticals. The contents of the Qingfang record include: operation room number, product name, batch number, production process, clearing date, inspection project and results, finger in charge of the Qingfang and the checkman signature. Qingling records should be included in the batch production record.

Section 4 packaging operation

Article 252 packaging operation procedures shall specify measures to reduce pollution and cross-pollution, confusion or error risk.

. The test results should be recorded.

Article 204 Before the packaging operation, it should also be checked the correct packaging material correctly, check the name, specification, quantity, quality state of the packaging product and the packaging materials used, and consistent with the process procedure.

Article 255 Each packaging operating place or packaging production line shall be identified to indicate the product name, specification, batch number and batch production in the package.

Article 206 If several packaging lines are packaged, isolation or other measures to effectively prevent pollution, cross-pollution or confusion should be taken.

Article 277 The dispensing container should be cleaned before the dispensing, avoid contaminants such as glass debris, metal particles in the container.

Article 208 Products are distributed, and they should be signed in time after the sealing. If you fail to check in time, you should use the relevant operating procedures to avoid errors such as confusion or admission tags.

Article 209 The information (such as product batch number or validity) of the online printing or packaging can be checked, ensuring that it is correct and recorded. If manual print, check frequently should be added.

Article 210 Use a cut-cut label or print a label other than the packaging line, and special measures should be taken to prevent confusion.

Article 211 shall check the function of an electronic reading machine, a label counter or other similar device to ensure it accurately. Check should be recorded.

  The content of printing or molding on the 2122 packaging material should be clear, not easy to fade and erase.

During Article 213 During packaging, the intermediate control inspection of the product should include at least the following:
(1) Packaging appearance;
(2) Whether the packaging is complete;
(3) Whether the products and packaging materials are correct;
(4) Whether the print information is correct;
(5) Whether the function of the online monitoring device is normal.
The sample should not return from the packaging production line to prevent more confusion or pollution.

Article 214 If an abnormal situation in the packaging process, it is necessary to re-pack the product, and must be approved by special inspections and investigations. Repacking should be recorded in detail.

Article 215 In the material balance inspection, it is found that the product to be packaged products, print packaging materials, and the number of finished products should be investigated. Before the conclusion, the finished product must not be released.

At the end of the packaging, the remaining packaging materials that have been printed should be destroyed by the special person, and there is records. If the print packaging material of the unprinted batch number is retracted, it shall be performed in accordance with the operation procedure.

Chapter 10 Quality Control and Quality Assurance

First Quality Control Lab Management

Article 217 The personnel, facilities and equipment of the Quality Control Lab should be adapted to product nature and production scale.
The company usually does not entrust inspections. If it is necessary to entrust the inspection, the external laboratory shall be entrusted in accordance with the provisions of the inspection part in Chapter 11, and the external laboratory shall be instructed, but it should be explained in the inspection report.

Article 218 The person in charge of the quality control shall have enough management laboratory qualifications and experience to manage one or more laboratory of the same enterprise.

Article 219 The inspectors of the Quality Control Lab should at least have relevant professional secondary school or high school degree, and have passed the practice training related to the inspection operations that are engaged in the examination.

Article 220 Quality Control Labs shall be equipped with a necessary book such as a pharmacopoeia, a standard map, as well as standard substances such as standard or related items.

Article 211 The document of the quality control laboratory shall comply with the principles of Chapter VII and meet the following requirements:
(1) Quality control laboratory should have at least the following detailed documents:
Quality standard;
2. Sampling operation procedures and records;
3. Check the operating procedures and records (including the inspection record or laboratory work notepad);
4. Check the report or certificate;
5. The necessary environmental monitoring procedures, records and reports;
6. The necessary inspection methods verify reports and records;
7. Instrument calibration and equipment use, clean, maintenance operation procedures and records.
(2) The inspection and record of each batch of drugs shall include intermediate products, quality inspection records for packaging products and finished products, can trace all relevant quality inspection of the drugs;
(3) It is advisable to maintain some data (such as test data, environmental monitoring data, microbial monitoring data for pharmaceutical water);
(4) In addition to the information information related to the batch record, other original materials or records should be saved for easy access.

Article 222 Sampling shall meet at least the following requirements:
(1) The personnel of the quality management department have the right to enter the production area and the storage area for sampling and investigation;
(2) The operating procedures should be specified in detail in accordance with the approval of the approval of the operating procedures.
1. Authorized sampler;
2. Sampling method;
3. Appliances for office;
4. Sample quantity;
5. Separate method;
6. Store the type and state of the sample container;
7. Dispose and identification of the remainder and sample after sampling;
8. Sampling Precautions, including preventive measures taken to reduce the various risks produced by the sampling process, especially sampling of sterile or hazardous materials, and prevention of contamination and cross-contamination in the sampling process;
9. Storage conditions;
10. Cleaning methods and storage requirements for sampling equipment.
(3) The sampling method should be scientific and reasonable to ensure the representation of the sample;
(4) The sample should be capable of representing the product or material of the sampled batch, and other samples can also be taken to monitor the most important links in the production process (such as the beginning or end of production);
(5) The container of the sample should be labeled, indicating the sample name, lot number, sampling date, which packaging container, sample person, etc.
(6) The sample should be preserved in accordance with the specified storage requirements.

Article 223 The inspection of materials and different production stages should meet at least the following requirements:
(1) Enterprises should ensure that drugs are tested in accordance with registered approval;
(2) If one of the following circumstances, the test method shall be verified:
1. Adopt new inspection methods;
2. The test method needs to be changed;
3. Test methods that are not received by the "People's Republic of China Pharmacopoeia" and other statutory standards;
4. Other test methods required for regulations require verification.
(3) The enterprise should confirm the inspection method to ensure that the inspection data is accurate and reliable;
(4) The inspection should have a written operation procedure, and the methods used, instruments and equipment are specified, and the contents of the inspection operation procedures shall be consistent with the verified or verified inspection method;
(5) Test should be traceable record and should be reviewed to ensure that the results are consistent with records. All calculations should be strictly checked;
(6) The inspection record should include at least the following:
1. Names, dosage forms, specifications, batch numbers or supplies, and indicate the name or source of suppliers and producers (such as different) if necessary;
2. The quality standards and inspection operation procedures are based on the basis;
3. Test the model and number of the instrument or equipment used;
4. Sources and batch numbers for the preparation batch number of the test and medium used;
5. Test information about the animals used;
6. Inspection process, including the preparation of the solution, each specific inspection operation, the necessary environmental temperature and humidity;
7. Inspection results, including observation, calculations, and maps or graphs, and the basis for inspection report number;
8. Test date;
9. Signature and date of inspectors;
10. Test, calculate the signature and date of the reviewer.
(7) All intermediate controls (including intermediate controlling by producers) shall be carried out in accordance with the approval by the quality management department, and the inspection should be recorded;
(8) The laboratory capacity analysis should be quality inspection with glass instruments, reagents, test solutions, and medium;
(9) The test experimental animal should be inspected or quarantined before use. Raising and management should comply with relevant experimental animal management regulations. Animals should be identified and should be saved for historical records.

Article 224 The quality control laboratory shall establish an operational procedure for inspection results. Any test results exceed the standard must be a complete survey in accordance with the operating procedures, and there is a corresponding record.

Article 225 If a company is preserved, the product sample is used for drug quality traceability or investigation. Samples for product stability test are not subject to the procedure.
Stamping should meet at least the following requirements:
(1) The procedure should be managed in accordance with the operating procedures;
(2) The material or product of the sample should be able to represent the sampled batch;
(3) The stamp of the finished product:
1. Each drug should have a matter; if a batch of medicines are packaged several times, then at least one of the smallest commercial packaging products should be retained each time.
2. The packaging form of the remaining packaging should be the same as the manufacture of drugs. If the stamps of the raw materials cannot adopt a commercially available packaging form, analog packaging can be used;
3. The number of post-samples for each drug should be at least at least at least two full-examination (sterile examination and hot gant examination, etc.);
4. If it does not affect the packaging integrity of the stamp, at least one subject to the removal of the remaining in the case, if there is an abnormality, it should be thoroughly investigated and corresponding processing measures;
5. The removal observation should be recorded;
6. The subjects should be preserved at least one year after the storage conditions approved by the registered approval;
7. If the company terminates the production or closure of drugs, the retaining shall be saved and inform the local drug supervision and management department so that it can be allowed at any time when necessary.
(4) Treatment of materials:
1. Both the formulation produces a packaging material that is directly contacted with the drug with the drug should be contained. Packaging materials (such as infusion bottles) that are directly in contact with drugs, such as the finished product has a matter of removal, and it is not necessary to leave alone;
2. The amount of material of the material should meet at least the need for identification;
3. In addition to the poor stability of the random radioconics, the retaining materials for formulations (excluding solvents, gas or pharmaceutical water used during production process) and packaging materials directly in contact with drugs should be stored at least to the product. Two years after release. If the validity period of the material is short, the stamp time can be shortened accordingly;
4. The material of the material should be stored in accordance with the prescribed conditions, and it should also be appropriately packaged as necessary.

Article 26 The management of reagents, test solutions, medium and testing bacteria should meet at least the following requirements:
(1) The reagents and medium should be purchased from a reliable supplier, and the supplier should be evaluated if necessary;
(2) There should be a record of receiving reagents, test solutions, and medium, if necessary, should be labeled on the reagent, test solution, and medium container;
(3) The reagents, test and medium should be prepared, stored, and used in accordance with relevant regulations or instructions. In special cases, the reagent should also be identified or other tests before receiving or using;
(4) Try solutions and formulated medium should be labeled in the formulation number, formulated date, and the name of the formulation, and has a formulation (including sterilization) record. Unstable reagents, test and medium should be labeled the validity period and special storage conditions. The standard liquid, the titration liquid should also be labeled the date and correction factor of the last marked, and it is standardized;
(5) The prepared medium should be suitably inspected and have related records. The use record should be used;
(6) There should be the various types of verification needed to be inspected, and the operational procedures and corresponding records of the hyperviscus preservation, passage, use, destruction should be established;
(7) The hyperplasia should have the appropriate identification, including at least a bacteria name, number, generation, passage date, passage to operator;
(8) The hypervilus should be stored in accordance with the specified conditions, and the storage method should not have a negative impact on the growth characteristics of the test.

Article 27 The management of standards or controls should meet at least the following requirements:
(1) Standards or references should be stored and used in accordance with regulations;
(2) Standards or controls should have appropriate logos, including at least name, batch number, preparation date (if), validity (if any), first open date, content or titer, storage conditions;
(3) If enterprises need homemade work standards or antiques, the quality standards of work standards or refers should be established and the preparation, identification, inspection, approval and storage of the operation procedures, and each batch of work standards or reference should be identified. Standards or controls are laminated and determine the validity period, and should also be stable during the validity period of the validity or content of the test. The process and results of the standard should have corresponding records.

The second quarter of materials and products release

Article 228 shall establish an operational procedure for approved by the material and product approved, identify the standards, responsibilities, and corresponding records.

Article 229 The release of materials should meet at least the following requirements:
(1) The quality evaluation content of the material should include at least manufacturer's inspection report, material packaging integrity and sealing and inspection results;
(2) The quality assessment of materials should have a clear conclusion, such as approvement, unqualified or other decisions;
(3) Materials should be approved by the designated personnel.

Article 230 The release of products should meet at least the following requirements:
(1) Before approved, each batch of pharmaceuticals should be given to quality assessment, guaranteeing drugs and their production, should comply with registration and this specification, and confirm the following contents:
1. The main production process and inspection method are verified;
2. All necessary inspections have been completed, and consider actual production conditions and production records.
3. All necessary production and quality control have been completed and signed by the relevant executive personnel;
4. Changes have been processed according to the relevant procedures, and the changes approved by the drug supervision and management department have been approved;
5. All necessary sampling, inspection, and review of all necessary sampling, inspection, inspection and review are completed for changes or deviations;
6. All deviations related to the batch have clearly explained or explained, or have been thoroughly investigated and appropriate; if the deviation involves other batch products, it should be handled.
(2) The quality assessment of the drug should have a clear conclusion, such as approved, unqualified or other decisions;
(3) Each drug should be approved by the quality of affected by quality;
(4) Vaccine products, blood products, in vitro diagnostic reagents for blood source screening, and other biological products stipulated in the State Food and Drug Administration, the certificate of issuance should also be obtained.

Investigation of continuous stability of third quarters

Under storage conditions, meet the requirements of quality standards.

Article 232 The continuous stability investigation is mainly for commercially available packaging drugs, but it also needs to be sealed with product. For example, when the package is completed before the package, or from the production plant to the packaging factory, it is necessary to have a long-term storage, and the effects of the product stability after packaging should be evaluated under the corresponding environmental conditions. In addition, it is also considered that an intermediate product having a long storage time is investigated.

Article 233 The persistent stability investigation shall have a survey plan, and the results should be reported. Equipment (especially stability test equipment or facilities) for sustained stability should be confirmed and maintained in accordance with the requirements of Chapter VII and Chapter V.

Article 234 The time for continuous stability should cover the validity period of the drug, and the investigation program should include at least the following:
(1) Each specification, the number of studies of each production batch drug;
(2) The relevant physical, chemical, microorganisms and biological test methods can consider the use of stability inspection exclusive test methods;
(3) the basis for inspection methods;
(4) Qualified standards;
(5) Description of container sealing systems;
(6) Test interval (test time point);
(7) Storage conditions (should adopt the long-term stability test standard conditions stipulated by the Pharmacopoeia "of the People's Republic of China corresponding to the drug storage conditions);
(8) Inspection projects, such as projects included in the test items less than the quality standards of the finished product, should be explained.

Article 235 The number of exams and inspection frequencies shall be able to obtain sufficient data for trend analysis. Usually, each specification, a drug in each inner packaging form, at least one batch at least once, unless there is no production.

Article 236 In some cases, the number of batches should be added in additional to the continuous stability inspection, such as a drug such as major changes or production and massive deviations should be included in stability. In addition, the batch of re-process, rework or recovery should also be considered, unless the verification and stability are over.

Article 237 Keyperesses, especially quality controllers, should understand the results of sustained stability. When the continuous stability is not in the production of products to be packaged, the products should be carried out, the relevant parties should have a written agreement, and the results of sustained stability inspection should be preserved to review the drug supervision and management department.

Article 238 shall investigate the results or important abnormal trends that do not meet quality standards. For any result, it is not compliant with the results or major adverse trends. Enterprises should consider whether it is possible to affect the listed drugs. If necessary, the survey results and measures should be reported to the local drug supervision and management department.

Article 239 The summary report shall be written according to the prevailing of all data sheets, including the phase of the investigation, and preservation. The summary report should be reviewed regularly.

Section IV Change Control

Article 240 If an enterprise shall establish a change control system to evaluate and manage all changes in product quality. The changes required to be approved by the drug supervision and management should be implemented after approval.

And implementation. The quality management department should designate the special person responsible for change control.

Article 242 Changes shall assess its potential impact on product quality. Enterprises can classify changes in the level of changes (such as primary, secondary changes) based on changes in the nature, range, and product quality. Judging the verification required by the change, additional inspection and stability investigation should have a scientific basis.

Article 243 After the quality of product quality is proposed by the application departments, it shall be evaluated and implemented and explicitly implemented by the quality management department. The implementation should have a corresponding complete record.

to evaluate. If the change may affect the validity of the drug, the quality assessment should also include stability inspection of the drug after the implementation of the implementation.

Article 245 When the implementation is implemented, it should be ensured that the documents related to the change have been revised.

Article 246 The quality management department shall save all changes and records.

Section 5 Deviation Treatment

Article 247 The person in charge of each department shall ensure that all personnel perform the production process, quality standards, inspection methods, and operation procedures to prevent deviations.

Article 248 If an enterprise shall establish an operational procedure for deviation, a report, record, investigation, processing, and corrective actions taken, and corresponding records.

Article 249 Any deviation shall evaluate its potential impact on product quality. Enterprises can classify deviations (such as significant, secondary deviation), and the assessment of major deviations should also consider whether the product has additional inspection and the effects of product validity period should also be considered in need of product quality. If necessary, a product involving major deviations should be stabilized.

Thorough investigations from the quality management department to other departments and have an investigation report. The deviation investigation report shall be reviewed and signed by the designated personnel of the quality management department.
Enterprises should also take precaution to effectively prevent similar deviations from happening again.

Article 251 The quality management department shall be responsible for the classification of deviations, save the deviation survey, and the documentation and records.

Section 6 Corrective Measures and Preventive Measures

Article 252 Enterprises shall establish a corrective measures and preventive measures to investigate and take corrective and preventive measures for complaints, recall, deviation, self-test or external inspection results, process performance and quality monitoring trends. The depth and form of the survey should be adapted to the level of risk. Corrective actions and preventive measures should be able to enhance understanding of products and processes, improve products and processes.

Article 253 Enterprises shall establish a procedure for implementing corrective and preventive measures, with at least the content:
(1) Analysis of complaints, recall, deviation, self-test or external examination results, process performance and quality monitoring trends, and other source of quality data, identify existing and potential quality problems. Appropriate statistical methods should be adopted if necessary;
(2) The investigation and product, process and quality assurance system are related to the system;
(3) Determine the correction and preventive measures required to prevent problems again;
(4) Evaluation of the rationality, effectiveness and adequacy of corrective and preventive measures;
(5) The changes in all the occurrences of the implementation correction and preventive measures should be recorded;
(6) Ensuring that the relevant information has been passed to the direct person in charge of the quality and prevention issues;
(7) Ensuring information and their corrections and precautions have been reviewed through senior management.

Article 254 These implementation corrections and preventive measures shall be recorded and stored by the quality management department.

Section 7 Suppliers' Evaluation and Approval

Vendors who meet the requirements exercise the veto.
The determination of the main materials should be comprehensively considering the factors such as the quality risks, materials of materials and materials on the quality of drugs.
The personnel legal representative, the person in charge of the company and other sectors shall not interfere with the quality management department's independent quality assessment of material suppliers.

Article 256 shall establish a material supplier assessment and approval of the operating procedures, clarify the qualifications of suppliers, the principles, quality assessment methods, assessment standards, and materials approved by materials.
If the quality assessment needs to adopt the on-site quality audit method, the composition and qualification of the audit content, cycle, and auditors should also be clarified. It is necessary to use small amounts of samples to be produced, and it should also be clearly produced by mass production, production process, product quality standards, stability inspection programs.

Article 257 The quality management department shall designate a special personnel responsible for material supplier quality assessment and on-site quality audit, distribution of qualified suppliers. The designated person should have relevant regulations and expertise, with sufficient quality assessment and practice experience in the on-site quality audit.

Article 258 The on-site quality audit shall verify the authenticity of the supplier qualification documents and inspection reports, and verify that it has inspection conditions. It should be checked for its personnel, plant facilities and equipment, material management, production process and production management, quality control laboratories, etc. to comprehensively assess its quality assurance system. On-site quality audit should have a report.

Article 259 If necessary, the samples provided by the main material suppliers shall be subjected to small batch test production, and the drugs for the drug production are stabilized.

Article 268 The quality management department shall at least include: Suppliers 'qualification documents, quality standards, inspection reports, enterprises' inspection data and reports of material samples. If the on-site quality audit and sample small batch test production should also include on-site quality audit reports, as well as the quality inspection report and stability inspection report of small test products.

Article 261 If a material supplier is changed, a new supplier shall conduct a quality assessment; change the main material supplier, it is necessary to investigate the verification and stability investigation of the product.

Wait, and update in time.

Article 263 Quality Management Department shall sign a quality agreement with the main material suppliers, and should clarify the quality responsibility of the two parties in the agreement.

Article 264 The quality management department shall regularly evaluate or on-site quality audit of material suppliers, review the quality test results, quality complaints and unqualified processing records. If the material, quality problems or production conditions, process, quality standards, and inspection methods may affect the key factors affecting quality, the relevant on-site quality audit should also be performed as soon as possible.

Audit report, product stability investigation report, regular quality review analysis report, etc.

Section 8 Product Quality Review Analysis

The direction of product and process improvement. The historical data of the previous review analysis should be considered, and the effectiveness of product quality review analysis should also be self-test.
When there is a reasonable scientific basis, quality review can be carried out according to the product of the product, such as solid preparations, liquid preparations, and sterile preparations.
Retrospective analysis should have a report.
The company should at least review the following cases:
(1) All changes in the raw materials used in the product, especially the raw materials from the new supplier;
(2) The test results of key intermediate control points and finished products;
(3) All batches and surveys do not meet quality standards;
(4) All major deviations and related surveys, the effectiveness of rectification measures and preventive measures taken;
(5) All changes in the production process or inspection method;
(6) All changes have been registered by drugs that have been approved or filed;
(7) Results and any bad trend of stability inspection;
(8) All returns, complaints, recalls and investigations due to quality reasons;
(9) Implementation and effects of corrective actions related to product technology or equipment;
(10) Newly approved and changed drugs, the work should be completed after the registration is required;
(11) Related equipment and facilities, such as air conditioning purification systems, water systems, compressed air, etc.
(12) Technical contract fulfillment of commissioning production or inspection.

Article 267 The results of the review shall be evaluated, and whether to take corrective and preventive measures or re-confirmation or re-verification, and timely, the rectification is completed.

Article 268 When the drug commissioning, the principal and the trustee should have a written technical agreement, stipulate the responsibility of the parties in the analysis of product quality, and ensure that product quality review analysis is on time and meets the requirements.

Ninth complaints and adverse reactions report

Article 269 shall establish a drug adverse reaction report and monitoring management system, and set up specialized agencies and have a full-time personnel to manage.

Article 270 shall actively collect drug adverse reactions, and the adverse reactions should be recorded, evaluated, investigated, and treated in a timely manner, and the possible risk of controlling can be taken, and reports to the drug supervision and management department in accordance with the requirements.

Article 271 If an operational procedure shall establish a procedure for complaint registration, evaluation, investigation, and processing, and stipulate measures taken during a complaint that may have a possible product defect, including whether it is necessary to recall the drug from the market.

Article 272 It shall have a special person and enough auxiliary personnel to be responsible for the investigation and processing of quality complaints, all complaints, and investigations should be notified to the quality.

Article 273 All complaints shall register and review, complaints related to product quality defects shall be recorded in detail the details of complaints and investigations.

Article 274 It is discovered or suspected of having a defect in a batch of drugs, and should consider checking other batch of medicines to identify whether it is affected.

Article 275 The complaint survey and handling shall be recorded and the information of the computes is indicated.

Article 276 shall regularly review the analysis of complaints in order to find a need to vigilance, repeat, and may need to recall the drug from the market, and take appropriate measures.

Article 277 If an enterprise has a production mistake, a drug deterioration or other major quality problems shall be taken in a timely manner, and it should also be reported to the local drug supervision and management department if necessary.

Chapter 11 Entrusted Production and Entrustment Inspection

First section

Technical matters.

Article 279 All activities of entrusting production or entrustment inspections, including any changes to technology or other aspects, should comply with relevant requirements for drug production licenses and registration.

Second section

Article 280 The entrusting party shall assess the trustee that conduct on-site assessment of the conditions, technical level and quality management of the trustee, confirming that it has the ability to complete the support work, and guarantees the requirements of this specification.

Article 281 The entrusting party shall provide all the necessary information to the trustee to enable the trustee to properly implement the authorized operations in accordance with drug registration and other statutory requirements.
The principal should make the trustee fully understand the various issues related to product or operation, including product or operation of the environment, plant, equipment, personnel, and other materials or products may be harmful.

Article 282 The entrusting party shall supervise the whole process of the trusted production or inspection.

Article 283 The entrusting party shall ensure that the materials and products meet the corresponding quality standards.

Section 3

Article 284 The trustee must have enough factory buildings, equipment, knowledge and experience, and personnel to meet the requirements of the production or inspection work entrusted by the principal.

Article 285 The trustee shall ensure that the materials, intermediate products and the package to be packaged in the entrustment are suitable for scheduled purposes.

Article 286 The trustee shall not engage in activities that have adverse effects on the quality of products that entrust production or inspection.

The fourth level

The contracts signed between the 277th entrusting party and the trusted party should specify the duties of their own product production and control, and the technical provisions should be developed by pharmaceutical technology, inspection expertise, and competent personnel who are familiar with this standard. The work of entrusted production and inspection must meet the relevant requirements of drug production license and drug registration and agree with both parties.

Article 288 Contracts shall detail the quality controller to approve the procedures for each batch of drugs to ensure that each batch of products have been produced and inspected in accordance with drug registration requirements.

Article 289 The contract shall specify which responsible for the procurement, inspection, release, production and quality control of the material (including intermediate control), and should also provide for sampling and inspection.
In the case of entrusting test, the contract should specify whether the trustee is sampling in the factory building of the commission.

Accounting all records related to the quality of the evaluation product.

Article 291 Contracts shall clearly define that the principal can check or on-site quality audit of the trustee.

Article 292 The entrusted inspection contract shall be clearly appointed by the Trust to accept the drug supervision and management department.

Chapter 12 Product Shipping and Recall

First section

Article 293 Enterprises shall establish a product recall system, and it is necessary to quickly and effectively from the market to recall any group of products with safety hazards.

Article 294 If a product returned and recalled due to quality reasons shall be supervised in accordance with the provisions, there is evidence that there is evidence that the quality of the return product is not affected.

Section 2

Article 245 Each batch of products shall have a shipping record. According to the shipping record, it should be able to track the sales of each product. If necessary, it should be able to recover in time. The content of the shipping record should include: product name, specification, batch number, quantity, receipt unit and address, contact information, delivery date , Transportation, etc.

Article 296 The zero-head packaging of drug delivery is limited to two batch numbers as a bin, and all batch numbers should be indicated outside the box, and the blending record is established.

Article 297 The shipping record shall be preserved for at least one year after the drug validity period.

Section 3 call

Article 298 shall formulate a recall operating procedure to ensure the effectiveness of the recall.

Article 299 shall designate a special person responsible for organizing coordination and recall work and equipped with a sufficient number of people. The head of the product recall should be independent of sales and marketing departments; if the person in charge of the product recall is not a quality controller, it should notify the quality of the recall to recall.

Article 300 recalls shall be able to start at any time and quickly implement it.

Article 36, due to the problem of safety hazards, the product has been recalled from the market, and should immediately report to the local drug supervision and management department.

Article 322 Product recall heads shall be able to quickly access the drug delivery record.

Article 303 The product that has been recalled shall be identified, alone, properly stored, and wait for the final processing decision.

The progress process of the 304th recall should have a record and have a final report. The number of products, the number of recalls, and the quantity balance should be explained in the report.

Article 355 shall be evaluated regularly on the effectiveness of the product recall system.

Chapter 13 Self-examination

First section

Article 36 The quality management department shall regularly organize the company's self-test and monitor the implementation of this specification, and assess whether the enterprise meets the requirements of this specification, and proposes necessary corrections and preventive measures.

Second section self-inspection

Transportation and recall and other projects check.

Article 388 shall be independent, systematic, comprehensive self-test by enterprise designated personnel, or an independent quality audit of external personnel or experts.

Article 369 Self-test should have a record. After the self-test is completed, there should be self-test reports, including at least all situations, evaluation conclusions, and recommendations for correcting and preventive measures. Self-test should report to the enterprise senior management personnel.

Chapter 14.

Article 310 This specification is the basic requirements for the quality management of drug production. Special requirements for drugs or production quality management activities such as sterile drugs, biological products, blood products, are also developed by the State Food and Drug Administration in appendix.

Article 311 If an enterprise can adopt a verified alternative to the requirements of this specification.

Article 312 This specification The meaning of the term (sorted by Chinese Pinyin) is:
(1) packaging
All steps needed to be packaged into the finished product, including dispensing, post, etc. However, the sterile filling of the products in the aseptic production process, and the filling of the final sterilization product is not considered packaging.
(2) packaging materials
Materials used in pharmaceutical packaging include packaging materials and containers, printed packaging materials that are in direct contact with drugs, but do not include an outer packaging material for transmission.
(3) Operation procedures
Approved to guide equipment operation, maintain and clean, verify, environmental control, sampling and inspection, etc., also known as standard operating procedures.
(4) Products
Including the middle product of the drug, to be packaged products and finished products.
(5) Product life cycle
Products from the initial development, listed until all stages of delisting.
(6) finished products
All production steps and final packaging products have been completed.
(7) Re-processing
A batch of intermediate products that do not meet the quality standards of a production process or part or all of the products to be packaged are used to comply with the predetermined quality standards.
(8) Waiting for the package
Products that have not been packaged but have completed all other processing processes.
(9)
Refers to the original accessories, packaging materials, intermediate products, to be packaged in products or finished products, using physical means or other effective ways to isolate or distinguish it, waiting for the state of the release determined before it is allowed to be used for the production or listing sales.
(10) distribution
Refers to a series of operations of materials, intermediate products, and products, documents, production molds, etc. in the production process.
(11) Re-inspection
After a certain amount of time, the packaging material is stored for a certain period of time, and it is necessary to re-test the date of re-test by enterprise to ensure that it is still suitable for the scheduled purpose.
(12) shipping
Refers to a series of operations of enterprises to send products to distributors or users, including distribution, transportation, etc.
(13) rework
A batch of intermediate products that do not meet the quality standards of a production process or to be packaged, part of the finished product, and all the previous processes are used, and the same production process is used to comply with the predetermined quality standards.
(14) release
Quality evaluation of a number of materials or products, making an approval or putting the market or other decisions.
(Fifteen) senior management personnel
The highest level command and control enterprises in the enterprise, and those who have the power and responsibilities of the resource.
(16) Process Regulations
One or a set of documents developed to produce a specific number of finished products, including production prescription, production operation requirements and packaging operation requirements, stipulate the number, process parameters and conditions of the raw film and packaging materials, and the processing description (including intermediate control), pay attention Matters and other content.
(17) Supplier
Refers to the providers of materials, equipment, instruments, reagents, services, such as manufacturers, dealers, etc.
(18) recycling
In a particular production phase, a batch or number of products that previously produced or several batches that meet the product requirements of the previously produced quality is added to another batch of operations.
(19) Computerization System
Integrated systems for reporting or automatic control, including data input, electronic processing, and information output.
(20) cross-pollution
Mutual pollution occurs between different raw materials, accessories and products.
(21) calibration
Under the predetermined conditions, the measurement, recording, control instrument, or system indicating the value (especially the quantity) of the system, or the value represented by the physical quantity is determined, and the relationship between the corresponding reference standard amount is determined.
(22) Stage sex production
Refers to a total production area, a product is concentrated in a period of time, and then thoroughly cleaner for the corresponding shared production area, facilities, equipment, and industrial appliances, and replace another product.
(23) Clean area
A room (region), the building structure, equipment, and its use should be required to reduce the introduction, production and retention of contaminants in the region.
(Twenty-four) alert limit
The key parameters of the system are outside the normal range, but do not reach the corrective transmission limit, need to be alert, may need to take corrective measures.
(Twenty-five) correction limit
The key parameters of the system are outside acceptable criteria, which requires surveys and takes a limiting standard for corrective actions.
(Twenty-six) inspection results exceed
The test results exceed the statutory standards and all the cases of enterprises.
(Twenty-seven)
After one or several processing processes, there is a certain number of raw members, packaging materials or finished products that are expected to be equal and characteristic. To accomplish some production steps, it may be necessary to divide a batch of products into several sub-batchs and finally merge into a one-one batch. In the case of continuous production, the batch must correspond to the determined number of products having the expected average characteristics in the production, and the batch can be a fixed number or the amount of product produced within the fixed time period.
For example, oral or external solids, semi-solid formulations use the homogeneous product produced by mixing the same mixing equipment before molding or dispensing, oral or external liquid preparations in filling (sealing) before final mixing The homogeneous products produced by the drug solution are a batch.
(28) batch number
Used to identify a combination of unique numbers and (or) letters of a particular batch.
(Twenty-nine) batch record
Used to describe all documents and records for each batch of drug production, quality inspection and release audits, can trace all historical information related to the quality of finished products.
(Thirty) air lock room
The isolation space provided between two or several rooms (such as the rooms of different cleanliness levels) has two or multi-doors. The purpose of setting the air lock is to control the airflow when the person or material is inserted. There is a person's air lock between the air lock and the material atmosphere.
(Thirty) enterprise
In this specification, there is no specification, and the company specially refers to pharmaceutical production enterprises.
(32) confirmation
Certification of factory buildings, facilities, and equipment can operate correctly and achieve a range of activities that expected.
(Thirty-three) return
Refund the drug to the enterprise.
(Thirty-four) documents
The documents referred to in this specification include quality standards, process procedures, operating procedures, records, reports, etc.
(Thirty-five) materials
Refers to raw materials, excipients and packaging materials.
For example, the raw material of the chemical preparation refers to the raw material drug; the raw material of the biological product refers to the raw material; the raw materials of the Chinese medicine preparation refers to the Chinese herbal medicine, Chinese medicine drinking pieces and foreign traditional Chinese medicine extracts; the raw material of the raw materials is used in the production of raw materials. Other materials other than packaging materials.
(36) Material balance
Product or material actual production or actual use and the sum of the results and theoretical output or theoretical amount or theoretical amount, and consider the allowable deviation range.
(37) pollution
During production, sampling, packaging or re-packaged, storage or transportation, raw members, intermediate products, to be packaged, finished products are adversely affected by impurities or foreign matter with chemical or microbial properties.
(38) Verification
Prove that any operating procedure (or method), production process or system can achieve a series of activities of the expected results.
(39) Printing packaging materials
Refers to packaging materials having specifications and printed contents, such as print aluminum foil, labels, manual, carton, etc.
(Forty) raw material
In addition to packaging materials, any material used in drug production.
(41) Intermediate products
Refers to the product that completes some processing steps, there is still a further process to become a product to be packaged.
(Forty-two) intermediate control
Also known as process control, refers to ensuring that the product meets the relevant standards, and the process is monitored in production to perform various inspections made when necessary. Environment or device control can be regarded as part of intermediate control.

Article 333 This specification is implemented from March 1, 2011. According to Article 9 of the People's Republic of China Drug Administration, specific implementations and implementation steps are regulated by the State Food and Drug Administration.