股票代码：******

Good Manufacturing Practice for Pharmaceutical Products 2010 Revision

Published:

2015-12-13

Good Manufacturing Practice for Pharmaceutical Products (2010 Revision)

(Ministry of Health Order No. 79) Issued on February 12, 2011

Order of the Ministry of Health of the People's Republic of China

No. 79

The "Good Manufacturing Practice for Pharmaceutical Products (2010 Revision)" was reviewed and approved by the Ministry of Health's executive meeting on October 19, 2010, and is hereby promulgated, effective from March 1, 2011.

Minister Chen Zhu

January 17, 2011

Chapter 1 General Provisions

　　Article 1 To standardize pharmaceutical production quality management, these regulations are formulated in accordance with the "Drug Administration Law of the People's Republic of China" and the "Implementation Regulations of the Drug Administration Law of the People's Republic of China."

　　Article 2 Enterprises shall establish a pharmaceutical quality management system. This system shall cover all factors affecting drug quality, including all organized and planned activities to ensure that drug quality meets the intended use.

　　Article 3 These regulations, as part of the quality management system, are the basic requirements for pharmaceutical production management and quality control, aiming to minimize risks such as contamination, cross-contamination, confusion, and errors during drug production, ensuring continuous and stable production of drugs that meet intended use and registration requirements.

　　Article 4 Enterprises shall strictly implement these regulations, adhere to honesty and integrity, and prohibit any false or deceptive behavior.

Chapter 2 Quality Management

Section 1 Principles

　　Article 5 Enterprises shall establish quality objectives that meet pharmaceutical quality management requirements, systematically implementing all safety, efficacy, and quality control requirements related to drug registration throughout the entire process of drug production, control, product release, storage, and shipment, ensuring that the produced drugs meet intended use and registration requirements.

　　Article 6 Senior management of enterprises shall ensure the achievement of established quality objectives. Personnel at different levels, as well as suppliers and distributors, shall participate and assume their respective responsibilities.

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

Section 2 Quality Assurance

　　Article 8 Quality assurance is part of the quality management system. Enterprises must establish a quality assurance system and a complete documentation system to ensure the effective operation of the system.

　　Article 9 The quality assurance system shall ensure:

　　(1) The design and research and development of drugs reflect the requirements of these regulations;

　　(2) Production management and quality control activities comply with these regulations;

　　(3) Management responsibilities are clearly defined;

　　(4) Raw materials, excipients, and packaging materials purchased and used are correct and accurate;

　　(5) Intermediate products are effectively controlled;

　　(6) Implementation of confirmation and validation;

　　(7) Production, inspection, testing, and review are strictly conducted according to procedures;

　　(8) Each batch of products is released only after approval by the authorized quality personnel;

　　(9) Appropriate measures are in place to ensure drug quality during storage, shipment, and subsequent operations;

　　(10) The effectiveness and suitability of the quality assurance system are regularly checked and evaluated according to self-inspection procedures.

　　Article 10 Basic requirements for pharmaceutical production quality management:

　　(1) Develop production processes, systematically review and demonstrate their ability to consistently produce products that meet requirements;

　　(2) Production processes and significant changes are validated;

　　(3) Provide necessary resources, including at least:

　　1. Personnel with appropriate qualifications and training;

　　2. Adequate facilities and space;

　　3. Suitable equipment and maintenance support;

　　4. Correct raw materials, excipients, packaging materials, and labels;

　　5. Approved process and operating procedures;

　　6. Appropriate storage and transportation conditions.

　　(4) Operating procedures shall be written in accurate and understandable language;

　　(5) Operators shall be trained to operate correctly according to operating procedures;

　　(6) The entire production process shall be recorded, and deviations shall be investigated and documented;

　　(7) Batch records and shipment records shall be able to trace the complete history of the batch and be properly stored and easily accessible;

　　(8) Reduce quality risks during drug shipment;

　　(9) Establish a drug recall system to ensure the recall of any batch of products that have been shipped and sold;

　　(10) Investigate causes of drug complaints and quality defects, take measures to prevent recurrence of similar quality defects.

Section 3 Quality Control

　　Article 11 Quality control includes corresponding organizational structures, documentation systems, sampling, and testing to ensure that materials or products undergo necessary inspections before release, confirming their quality meets requirements.

　　Article 12 Basic requirements for quality control:

　　(1) Appropriate facilities, equipment, instruments, and trained personnel shall be provided to effectively and reliably complete all quality control activities;

　　(2) Approved operating procedures shall be in place for sampling, inspection, testing of raw materials, excipients, packaging materials, intermediate products, products to be packaged, and finished products, as well as stability studies and environmental monitoring when necessary, to ensure compliance with these regulations;

　　(3) Sampling of raw materials, excipients, packaging materials, intermediate products, products to be packaged, and finished products shall be performed by authorized personnel according to prescribed methods;

　　(4) Testing methods shall be validated or verified;

　　(5) Records shall be kept for sampling, inspection, and testing, and deviations shall be investigated and documented;

　　(6) Materials, intermediate products, products to be packaged, and finished products must be inspected and tested according to quality standards, with records maintained;

　　(7) There should be sufficient samples of materials and finished products in the final packaging for necessary inspection or testing; except for finished products with excessively large final packaging containers, the sample packaging of finished products should be the same as the final packaging.

Section 4 Quality Risk Management

　　Article 13 Quality risk management is a systematic process of assessing, controlling, communicating, and reviewing quality risks throughout the entire product lifecycle using a prospective or retrospective approach.

　　Article 14 Quality risks should be assessed based on scientific knowledge and experience to ensure product quality.

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

Chapter 3 Organization and Personnel

Section 1 Principles

　　Article 16 Enterprises should establish management organizations suitable for pharmaceutical production and have an organizational chart.

　　Enterprises should set up an independent quality management department responsible for quality assurance and quality control. The quality management department may be divided into quality assurance and quality control departments.

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

　　Article 18 Enterprises should equip a sufficient number of management and operational personnel with appropriate qualifications (including education, training, and practical experience), and clearly define the responsibilities of each department and position. Responsibilities should not be omitted, and overlapping responsibilities should be clearly defined. No individual should bear excessive responsibilities.

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

　　Article 19 Responsibilities are generally not to be delegated to others. If delegation is necessary, the responsibilities may be entrusted to designated personnel with equivalent qualifications.

Section 2 Key Personnel

　　Article 20 Key personnel should be full-time employees of the enterprise and at least include the enterprise leader, production management leader, quality management leader, and quality authorized person.

　　The quality management leader and production management leader shall not hold both positions simultaneously. The quality management leader and quality authorized person may hold both positions. Operating procedures should be established to ensure the quality authorized person independently performs their duties without interference from the enterprise leader or others.

　　Article 21 Enterprise Leader

　　The enterprise leader is the primary person responsible for drug quality and is fully responsible for the daily management of the enterprise. To ensure the enterprise achieves quality objectives and produces drugs according to this standard, the enterprise leader should provide necessary resources, reasonably plan, organize, and coordinate, and ensure the quality management department independently performs its duties.

Article 22 Production Management Leader

　 (1) Qualifications:

　　The production management leader should have at least a bachelor's degree in pharmacy or a related field (or an intermediate professional title or licensed pharmacist qualification), with at least three years of practical experience in drug production and quality management, including at least one year of drug production management experience, and have received professional training related to the products produced.

　 (2) Main Responsibilities:

　　1. Ensure drugs are produced and stored according to approved process procedures to guarantee drug quality;

　　2. Ensure strict implementation of various operating procedures related to production operations;

　　3. Ensure batch production records and batch packaging records are reviewed by designated personnel and submitted to the quality management department;

　　4. Ensure maintenance of plants and equipment to keep them in good operating condition;

　　5. Ensure completion of various necessary validation tasks;

　　6. Ensure production-related personnel receive necessary pre-job and continuing training, and adjust training content as needed based on actual requirements.

Article 23 Quality Management Leader

　　(1) Qualifications:

　　The quality management leader should have at least a bachelor's degree in pharmacy or a related field (or an intermediate professional title or licensed pharmacist qualification), with at least five years of practical experience in drug production and quality management, including at least one year of drug quality management experience, and have received professional training related to the products produced.

　　(2) Main Responsibilities:

　　1. Ensure raw materials, packaging materials, intermediates, products to be packaged, and finished products meet registered approved requirements and quality standards;

　　2. Ensure batch records are reviewed before product release;

　　3. Ensure completion of all necessary inspections;

　　4. Approve quality standards, sampling methods, inspection methods, and other quality management operating procedures;

　　5. Review and approve all quality-related changes;

　　6. Ensure all major deviations and inspection result exceedances have been investigated and handled promptly;

　　7. Approve and supervise outsourced inspections;

　　8. Supervise maintenance of plants and equipment to keep them in good operating condition;

　　9. Ensure completion of various necessary confirmations or validations, and review and approve confirmation or validation plans and reports;

　　10. Ensure completion of self-inspections;

　　11. Evaluate and approve material suppliers;

　　12. Ensure all product quality-related complaints have been investigated and handled promptly and correctly;

　　13. Ensure completion of ongoing product stability study plans and provide stability study data;

　　14. Ensure completion of product quality review analysis;

　　15. Ensure quality control and quality assurance personnel have received necessary pre-job and continuing training, and adjust training content as needed based on actual requirements.

　　Article 24 The production management leader and quality management leader generally share the following responsibilities:

　　(1) Review and approve product process procedures, operating procedures, and other documents;

　　(2) Supervise plant hygiene conditions;

　　(3) Ensure key equipment is qualified;

　　(4) Ensure completion of production process validation;

　　(5) Ensure all relevant personnel in the enterprise have received necessary pre-job and continuing training, and adjust training content as needed based on actual requirements;

　　(6) Approve and supervise contract manufacturing;

　　(7) Determine and monitor storage conditions for materials and products;

　　(8) Keep records;

　　(9) Supervise the implementation status of this specification;

　　(10) Monitor factors affecting product quality.

　　Article 25 Quality Authorized Person

　　(1) Qualifications:

　　The Quality Authorized Person shall have at least a bachelor's degree in pharmacy or a related major (or an intermediate professional technical title or licensed pharmacist qualification), with at least five years of practical experience in pharmaceutical production and quality management, and have engaged in pharmaceutical production process control and quality inspection work.

　　The Quality Authorized Person shall possess the necessary professional theoretical knowledge and must undergo training related to product release before independently performing their duties.

　　(2) Main Responsibilities:

　　1. Participate in the establishment of the enterprise quality system, internal self-inspection, external quality audits, validation, as well as quality management activities such as adverse drug reaction reporting and product recalls;

　　2. Assume responsibility for product release, ensuring that the production and inspection of each batch of released products comply with relevant regulations, drug registration requirements, and quality standards;

　　3. Before product release, the Quality Authorized Person must issue a product release review record in accordance with the requirements of item 2 above, and include it in the batch record.

Regulations on Reporting and Monitoring of Adverse Drug Reactions

Good Supply Practice for Pharmaceutical Products

Add:

Address: No. 198 Huoju Avenue, Jinggangshan Economic & Technological Development Zone, Ji’an, Jiangxi, China

Board Office:

Domestic Sales:

International Sales: