GMP revised in 2010

 

 

The Good Manufacturing Practice for Drugs (revised in 2010), which was deliberated and adopted at the ministerial meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall come into force as of March 1, 2011.

 

 

 

Minister Chen Zhu
January 17, 2011

 

 

 

 

Chapter I General Provisions
Article 1 In order to standardize the quality control of drug production, this Code is formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China and the Regulations for the Implementation of the Pharmaceutical Administration Law of the People's Republic of China.
Article 2 An enterprise shall establish a drug quality management system. The system shall cover all factors affecting the drug quality, including all organized and planned activities to ensure that the drug quality meets the intended use.
Article 3 As a part of the quality management system, this Code is the basic requirement for drug production management and quality control, aiming to minimize the risks of pollution, cross contamination, confusion, errors, etc. in the drug production process, and ensure the continuous and stable production of drugs that meet the intended use and registration requirements.
Article 4 The enterprise shall strictly implement this Code, adhere to honesty and trustworthiness, and prohibit any false or deceptive behavior.
Chapter II Quality Management
Section I Principles
Article 5 An enterprise shall establish quality objectives that meet the requirements of drug quality control, systematically implement all the requirements for safety, effectiveness and quality control of drug registration throughout 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 the enterprise shall ensure the achievement of the established quality objectives, and the personnel at different levels, suppliers and distributors shall jointly participate and assume their respective responsibilities.
Article 7 An enterprise shall be equipped with sufficient and qualified personnel, workshops, facilities and equipment to provide the necessary conditions for achieving the quality objectives.
Section 2 Quality Assurance
Article 8 Quality assurance is a part of the quality management system. Enterprises must establish a quality assurance system and a complete document system to ensure the effective operation of the system.
Article 9 The quality assurance system shall ensure that:
（1） The design and R&D of drugs reflect the requirements of this specification;
（2） Production management and quality control activities meet the requirements of this specification;
（3） Clear management responsibilities;
（4） The raw and auxiliary materials and packaging materials purchased and used are correct;
（5） Intermediate products are effectively controlled;
（6） Implementation of confirmation and verification;
（7） Carry out production, inspection, inspection and recheck in strict accordance with the procedures;
（8） Each batch of products can be released only after being approved by the quality authorized person;
（9） Appropriate measures are taken to ensure the quality of drugs during storage, shipment and subsequent operations;
（10） Regularly check and evaluate the effectiveness and applicability of the quality assurance system according to the self inspection operation procedures.
Article 10 The basic requirements for the quality control of drug production are as follows:
（1） Formulate production process, systematically review and prove that it can continuously and stably produce qualified products;
（2） The production process and its major changes have been verified;
（3） Allocate the required resources, at least including:
1. Personnel with appropriate qualifications and qualified training;
2. Sufficient workshop and space;
3. Applicable equipment and maintenance guarantee;
4. Correct raw and auxiliary materials, packaging materials and labels;
5. Approved process procedures and operating procedures;
6. Proper storage and transportation conditions.
（4） Operating procedures shall be formulated in accurate and understandable language;
（5） The operators are trained to operate correctly according to the operating procedures;
（6） The whole production process shall be recorded, and deviations shall be investigated and recorded;
（7） Batch records and shipping records should be able to trace the complete history of batch products, and properly kept for easy reference;
（8） Reduce the quality risk during drug delivery;
（9） Establish a drug recall system to ensure that any batch of products that have been shipped for sale can be recalled;
（10） Investigate the causes of drug complaints and quality defects, and take measures to prevent similar quality defects from occurring again.
Section III Quality Control
Article 11 The quality control includes the corresponding organization, document system, sampling, inspection, etc., to ensure that the necessary inspection is completed before the release of materials or products to confirm that their quality meets the 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 related activities;
（2） There shall be approved operating procedures for sampling, inspection and inspection of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products, as well as stability inspection of products. When necessary, environmental monitoring shall be carried out to ensure compliance with the requirements of this specification;
（3） The authorized personnel shall take samples of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products according to the specified methods;
（4） The inspection method shall be verified or confirmed;
（5） Sampling, inspection and inspection shall be recorded, and deviations shall be investigated and recorded;
（6） Materials, intermediate products, products to be packaged and finished products must be inspected and inspected according to quality standards, and records must be kept;
（7） The materials and the final packaged finished products shall have enough reserved samples for necessary inspection or inspection; Except for the finished products with oversized final packaging containers, the reserved sample packaging of the finished products shall be the same as the final packaging.
Section IV Quality Risk Management
Article 13 Quality risk management is a systematic process of evaluating, controlling, communicating and auditing quality risks in a forward-looking or retrospective manner throughout the product life cycle.
Article 14 The quality risk shall be assessed according to scientific knowledge and experience to ensure the product quality.
Article 15 The methods, measures, forms and documents adopted in the quality risk management process shall be consistent with the level of risk.
Chapter III Organization and Personnel
Section I Principles
Article 16 An enterprise shall establish an administrative organization suitable for drug production and have an organizational chart.
An enterprise shall establish an independent quality management department to perform the duties of quality assurance and quality control. The quality management department may establish 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. The personnel of the quality management department shall not delegate their responsibilities to the personnel of other departments.
Article 18 An enterprise shall be equipped with a sufficient number of management and operation personnel with appropriate qualifications (including education background, training and practical experience), and shall clearly define the responsibilities of each department and each post. Post responsibilities shall not be omitted, and cross responsibilities shall be clearly defined. Everyone should not have too many responsibilities.
All personnel shall clearly understand their responsibilities, be familiar with the requirements related to their responsibilities, and receive necessary training, including pre job training and continuing training.
Article 19 In general, duties shall not be entrusted to others. If it is really necessary to entrust, its responsibilities can be entrusted to a qualified designated person.
Section II Key Personnel
Article 20 Key personnel shall be full-time employees of the enterprise, and shall at least include the person in charge of the enterprise, the person in charge of production management, the person in charge of quality management and the person authorized for quality management.
The person in charge of quality management and the person in charge of production management shall not serve concurrently. The person in charge of quality management and the quality authorized person may serve concurrently. Operating procedures shall be formulated to ensure that the quality authorized person performs his duties independently and is not interfered by the person in charge of the enterprise and other personnel.
Article 21 Person in charge of the enterprise
The person in charge of the enterprise is the main person responsible for drug quality, and is fully responsible for the daily management of the enterprise. In order to ensure that the enterprise can achieve the quality objectives and produce drugs according to the requirements of this specification, the person in charge of the enterprise shall be responsible for providing necessary resources, reasonably planning, organizing and coordinating, and ensuring that the quality management department independently performs its duties.
Article 22 Person in charge of production management
（1） Qualification:
The person in charge of production management shall have at least a bachelor's degree in pharmacy or related majors (or an intermediate professional technical title or licensed pharmacist qualification), at least three years of practical experience in drug production and quality management, including at least one year of experience in drug production management, and have received professional knowledge training related to the products produced.
（2） Main responsibilities:
1. Ensure that drugs are produced and stored according to the approved process procedures to ensure drug quality;
2. Ensure strict implementation of various operating procedures related to production operation;
3. Ensure that batch production records and batch packaging records are reviewed by designated personnel and submitted to the quality management department;
4. Ensure the maintenance of plant and equipment to keep them in good operating condition;
5. Ensure to complete all necessary verification work;
6. Ensure that relevant production personnel receive necessary pre job training and continuing training, and adjust the training content according to actual needs.
Article 23 Person in charge of quality management
（1） Qualification:
The person in charge of quality management shall have at least a bachelor's degree in pharmacy or related majors (or an intermediate professional technical title or licensed pharmacist qualification), 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 knowledge training related to the products produced.
（2） Main responsibilities:
1. Ensure that raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products meet the requirements and quality standards approved by registration;
2. Ensure that the review of batch records is completed before product release;
3. Ensure all necessary inspections are completed;
4. Approve quality standards, sampling methods, inspection methods and other quality management operating procedures;
5. Review and approve all quality related changes;
6. Ensure that all major deviations and excessive inspection results have been investigated and handled in a timely manner;
7. Approve and supervise the entrusted inspection;
8. Supervise the maintenance of plant and equipment to keep them in good operating condition;
9. Ensure the completion of all necessary confirmation or verification work, review and approve the confirmation or verification scheme and report;
10. Ensure the completion of self inspection;
11. Evaluate and approve material suppliers;
12. Ensure that all complaints related to product quality have been investigated and handled timely and correctly;
13. Ensure to complete the continuous stability inspection plan of the product and provide the stability inspection data;
14. Ensure the completion of product quality review and analysis;
15. Ensure that the quality control and quality assurance personnel have received the necessary pre job training and continuing training, and adjust the training content according to the actual needs.
Article 24 The person in charge of production management and the person in charge of quality management usually have the following common duties:
（1） Review and approve documents such as process procedures and operating procedures of products;
（2） Supervise the sanitation of the plant area;
（3） Ensure that key equipment is confirmed;
（4） Ensure the completion of production process validation;
（5） Ensure that all relevant personnel of the enterprise have received the necessary pre job training and continuing training, and adjust the training content according to the actual needs;
（6） Approve and supervise the entrusted production;
（7） Determine and monitor the storage conditions of materials and products;
（8） Keep records;
（9） Supervise the implementation of this specification;
（10） Monitor factors affecting product quality.
Article 25 Quality Authorized Person
（1） Qualification:
The quality authorized person shall have at least a bachelor's degree in pharmacy or related majors (or an intermediate professional technical title or licensed pharmacist qualification), at least five years of practical experience in drug production and quality management, and have been engaged in drug production process control and quality inspection.
The quality authorized person shall have the necessary professional theoretical knowledge and receive the training related to product release before independently performing his duties.
（2） Main responsibilities:
1. Participate in the establishment of enterprise quality system, internal self inspection, external quality audit, verification, adverse drug reaction report, product recall and other quality management activities;
2. Undertake the responsibility of product release, and ensure 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 the product release audit record according to the requirements of Item 2 above and include it in the batch record.