Chapter I General Principles

Article 1 In order to standardize the quality management of pharmaceutical production, this specification is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and the Regulations for the Implementation of the Drug Administration Law of People's Republic of China (PRC).

Article 2 An enterprise shall establish a drug quality management system. The system should cover all factors affecting the quality of drugs, including all organized and planned activities, to ensure that the quality of drugs meets the intended use.

Article 3 As a part of the quality management system, this specification is the basic requirement of drug production management and quality control, aiming at minimizing the risks of pollution, cross-contamination, confusion and errors in the process of drug production, and ensuring the sustained and stable production of drugs that meet the expected use and registration requirements.

Article 4 Enterprises shall strictly implement these Standards, be honest and trustworthy, and prohibit any false or fraudulent acts.

Chapter II Quality Management

Section 1 Original Rules

Article 5 An enterprise shall establish quality objectives that meet the requirements of drug quality management, systematically implement the requirements of safety, effectiveness and quality control of drug registration in the whole process of drug production, control, product release, storage and shipment, and ensure that the drugs produced meet the intended use and registration requirements.

Article 6 The senior management of an enterprise shall ensure that the established quality objectives are achieved, and personnel at different levels, as well as suppliers and distributors, shall participate in and assume their respective responsibilities.

Article 7 An enterprise shall be equipped with sufficient qualified personnel, workshops, facilities and equipment to provide necessary conditions for achieving quality objectives.

Chapter III Institutions and Personnel

Section 1 Original Rules

Article 16 An enterprise shall establish a management organization suitable for drug production and have an organization chart.

An enterprise shall set up an independent quality management department to perform the duties of quality assurance and quality control. The quality management department may set up a quality assurance department and a quality control department respectively.

Article 17 The quality management department shall participate in all quality-related activities and be responsible for reviewing all documents related to this specification. Personnel in the quality management department shall not delegate their responsibilities to personnel in other departments.

Eighteenth enterprises should be equipped with a sufficient number of management and operation personnel with corresponding qualifications (including education, training and practical experience), and should clearly define the responsibilities of various departments and positions. Job responsibilities shall not be omitted, and overlapping responsibilities shall be clearly defined. Everyone should not bear too much responsibility.

All personnel should be clear and understand their responsibilities, be familiar with the requirements related to their responsibilities, and receive necessary training, including pre-job training and continuing training.

Nineteenth duties shall not be entrusted to others. If it is really necessary to entrust, its duties can be entrusted to designated personnel with considerable qualifications.

Chapter IV Factory Buildings and Facilities

Section 1 Original Rules

Article 38 The site selection, design, layout, construction, renovation and maintenance of the factory building must meet the requirements of pharmaceutical production, and can avoid pollution, cross-contamination, confusion and errors to the greatest extent, so as to facilitate cleaning, operation and maintenance.

Article 39 The site selection shall be based on the comprehensive consideration of the factory building and production protection measures, and the environment in which the factory building is located shall be able to minimize the pollution risk of materials or products.

Fortieth enterprises should have a clean and tidy production environment; The ground, road surface and transportation of the factory should not cause pollution to drug production; The overall layout of production, administration, living and auxiliary areas shall be reasonable and shall not interfere with each other; The direction of people flow and logistics in factories and workshops should be reasonable.

Article 41 The workshop shall be properly maintained, and the maintenance activities shall not affect the quality of drugs. The workshop shall carry out necessary cleaning or disinfection according to detailed written operation procedures.

Article 42 The workshop should have proper lighting, temperature, humidity and ventilation to ensure that the quality of products produced and stored and the performance of related equipment will not be directly or indirectly affected.

Article 43 Factories and equipment shall be designed and set up to effectively prevent insects or other animals from entering. Necessary measures should be taken to avoid using rodenticide, insecticide, fumigant and other pollution to equipment, materials and products.

Article 44 Appropriate measures shall be taken to prevent unauthorized personnel from entering. Production, storage and quality control areas should not be used as direct entrances for non-local employees.

Article 45 As-built drawings of factories, public facilities, fixed pipelines and other projects after construction or transformation shall be kept.

Chapter V Equipment

Section 1 Original Rules

Article 71 The design, selection, installation, modification and maintenance of equipment must conform to the intended use, and the risks of pollution, cross-contamination, confusion and mistakes should be reduced as much as possible to facilitate operation, cleaning and maintenance, and disinfection or sterilization should be carried out if necessary.

Article 72 Operating rules for the use, cleaning, maintenance and repair of equipment shall be established, and corresponding operating records shall be kept.

Article 73 Documents and records of equipment procurement, installation and confirmation shall be established and kept.

Chapter VI Materials and Products

Section 1 Original Rules

Article 102 The raw and auxiliary materials used in the production of drugs and the packaging materials that come into direct contact with drugs shall meet the corresponding quality standards. Ink used for direct printing of drugs should meet the requirements of edible standards.

Imported raw and auxiliary materials shall comply with the relevant state regulations on import management.

Article 103 Operating rules for materials and products shall be established to ensure the correct receipt, storage, distribution, use and delivery of materials and products, and to prevent pollution, cross-contamination, confusion and errors.

The handling of materials and products shall be carried out in accordance with the operating rules or process rules, and recorded.

Article 104 The determination and change of material suppliers shall be evaluated before purchasing and approved by the quality management department.

Article 105 The transportation of materials and products shall meet the requirements of ensuring quality. If there are special transportation requirements, the transportation conditions shall be confirmed.

Article 106 The receiving of raw and auxiliary materials, packaging materials in direct contact with drugs and printing and packaging materials shall have operating procedures, and all incoming materials shall be inspected to ensure that they are in conformity with the orders, and the suppliers shall be confirmed to have been approved by the quality management department.

The outer packaging of materials shall be labeled with specified information. Clean it if necessary. If it is found that the outer packaging is damaged or other problems that may affect the quality of materials, it should be reported to the quality management department for investigation and record.

Each receipt shall be recorded, including:

The name of the material on the delivery note and packaging container;

(2) Names and/or codes of materials used within the enterprise;

(3) Date of receipt;

(4) Names of suppliers and manufacturers (if different);

(5) Batch numbers marked by suppliers and manufacturers (if different);

(six) the total amount received and the number of packaging containers;

(seven) after receiving the batch number or serial number designated by the enterprise;

(eight) the relevant instructions (such as packaging conditions).

Article 107 After receiving materials and finished products, they shall be managed in a timely manner according to the pending inspection until they are released.

Article 108 Materials and products shall be stored and turned around in batches according to their nature, and the distribution and shipment shall conform to the principle of first-in first-out and first-out in the near future.

Article 109 Where computerized warehouse management is adopted, there shall be corresponding operating rules to prevent the confusion and errors of materials and products caused by special circumstances such as system failure and shutdown.

If a fully computerized warehouse management system is used for identification, materials, products and other related information do not need to be marked in written and readable form.

Chapter VIII Document Management

Section 1 Original Rules

The document 150 is the basic element of the quality assurance system. Enterprises must have correct written quality standards, production prescriptions, technological procedures, operating procedures and records.

Article 151 An enterprise shall establish operating rules for document management, and systematically design, formulate, review, approve and issue documents. Documents related to this specification shall be audited by the quality management department.

Article 152 The contents of the document shall meet the relevant requirements such as drug production license and drug registration, and help to trace back the historical situation of each batch of products.

Article 153 The drafting, revision, review, approval, replacement or revocation, copying, storage and destruction of documents shall be managed in accordance with the operating rules, and corresponding records of document issuance, revocation, copying and destruction shall be kept.

Article 154 The drafting, revision and examination and approval of documents shall be signed and dated by appropriate personnel.

Article 155 A document shall be marked with its title, type, purpose, document number and version number. Words should be accurate, clear and easy to understand, not ambiguous.

156th documents should be stored in a classified way, organized and easy to refer to.

Article 157 There shall be no mistakes when copying the original vouchers. Copied documents should be legible.

158th documents shall be regularly reviewed and revised; After the document is revised, it should be managed according to regulations to prevent the misuse of the old version. Documents distributed and used shall be the current approved texts, and invalid or old versions of documents shall not appear on the job site except for filing for future reference.

Article 159 Every activity related to this specification shall be recorded to ensure the traceability of product production, quality control and quality assurance. Records should leave enough space to fill in the data. Records should be filled in in time, the content is true, the handwriting is clear, easy to read and not easy to erase.

Article 160 Records, drawings and graphs automatically printed by production and inspection equipment shall be used as far as possible to mark the name and batch number of products or samples and the information of recording equipment, and the operator shall endorse the name and date.

Article 161 Records shall be kept clean and tidy, and shall not be torn up or altered at will. Any change in the record should be signed with name and date, and the original information should still be legible. If necessary, the reason for the change should be explained. If the record needs to be copied again, the original record shall not be destroyed and kept as an attachment of the copied record.

Article 162 Each batch of drugs shall have batch records, including batch production records, batch packaging records, batch inspection records, drug release audit records and other records related to the batch of products. Batch records shall be managed by the quality management department, and the storage period shall be at least one year after the expiry date of the drug.

Other important documents such as quality standards, process regulations, operation regulations, stability inspection, confirmation, verification and change shall be kept for a long time.

Article 163 Where electronic data processing systems, photographic techniques or other reliable means are used to record data, there shall be operating rules for the systems used; The accuracy of the records should be checked.

When using electronic data processing system, only authorized personnel can input or change data, and changes and deletions should be recorded; Password or other means should be used to control the login of the system; After the key data is input, it should be checked independently by others.

Batch records stored electronically should be backed up by magnetic tape, microfilm, paper copy or other methods to ensure the safety of records and easy access to data during storage.

Chapter IX Production Management

Section 1 Original Rules

Article 184 The production and packaging of all drugs shall be carried out in accordance with the approved technological procedures and operating procedures, and relevant records shall be kept to ensure that the drugs meet the prescribed quality standards and meet the requirements of drug production license and registration examination and approval.

Article 185 Operating rules for dividing production batches of products shall be established, and the division of production batches shall ensure the consistency of quality and characteristics of products in the same batch.

Article 186 Operating procedures for compiling drug batch numbers and determining production dates shall be established. A unique batch number should be compiled for each batch of drugs. Unless otherwise stipulated by law, the production date shall not be later than the operation start date of final mixing before product molding or filling (sealing), and the product packaging date shall not be used as the production date.

Article 187 The output and material balance of each batch of products shall be inspected to ensure that the material balance meets the prescribed limits. If there is any difference, it is necessary to find out the reason and confirm that there is no potential quality risk before it can be treated as a normal product.

Article 188 It is forbidden to produce drugs of different varieties and specifications at the same time in the same production operation room, unless there is no possibility of confusion or cross-contamination.

Article 189 At all stages of production, products and materials should be protected from microbial and other pollution.

Article 190 When producing dry materials or products, especially those with high activity, high toxicity or high allergy, special measures shall be taken to prevent the generation and spread of dust.

Article 191 All materials, intermediate products or containers, main equipment and necessary operation rooms of products to be packaged used in the production process shall be labeled or otherwise marked with the name, specification and batch number of the products or materials produced, and if necessary, the production process shall also be marked.

Article 192 The marks used for containers, equipment or facilities shall be clear and the format of the marks shall be approved by the relevant departments of the enterprise. In addition to using text description on the logo, different colors can also be used to distinguish the status of the marked object (such as pending inspection, qualified, unqualified or cleaned, etc.). ).

Article 193 The connection of pipelines and other equipment that transport products from one area to another area shall be inspected to ensure the correct connection.

Article 194 After each production, the site shall be cleaned up to ensure that no materials, products and documents related to this production are left in the equipment and workplace. Before the next production starts, the previous permission should be confirmed.

Article 195 Deviation from the technical regulations or operation regulations shall be avoided as far as possible. If there is any deviation, it shall be implemented according to Deviation Handling Operation Procedure.

Article 196 Access to a production plant shall be limited to approved personnel.

Chapter II XI Entrusted Production and Entrusted Inspection

Section 1 Original Rules

Article 278 In order to ensure the quality of the entrusted product and the accuracy and reliability of the entrusted inspection, the entrusting party and the entrusted party must sign a written contract to clarify the responsibilities of both parties, the contents of the entrusted production or inspection and relevant technical matters.

Article 279 All activities entrusted for production or inspection, including changes in technology or other aspects, shall meet the relevant requirements of drug production license and registration.

Chapter XII Product Transportation and Recall

Section 1 Original Rules

Article 293 An enterprise shall establish a product recall system to recall any batch of products with potential safety hazards from the market quickly and effectively when necessary.

Article 294 Products returned or recalled for quality reasons shall be destroyed under supervision in accordance with regulations, unless there is evidence that the quality of the returned products has not been affected.

Chapter 13 Self-inspection

Section 1 Original Rules

Article 306 The quality management department shall regularly organize enterprises to conduct self-inspection, monitor the implementation of this specification, evaluate whether the enterprises meet the requirements of this specification, and put forward necessary corrective and preventive measures.