Pharmaceutical production quality management regulations revised in 2010

Pharmaceutical production quality management regulations (revised in 2010)

 

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

 

Ministry of Health of the People's Republic of China

 

No. 79

 

 

 

The "Good Manufacturing Practices (2010 Revision)" was reviewed and approved by the Ministry of Health's ministerial meeting on October 19, 2010. It is now released and will be implemented as of March 1, 2011.

 

 

 

Minister Chen Hao

January 17, 2011

 

 

 

 

Chapter 1 General

 

Article 1 In order to standardize the quality management of pharmaceutical production, this Code is 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 An enterprise shall establish a drug quality management system. The system should cover all factors affecting the quality of the drug, including all organized, planned activities that ensure the quality of the drug meets its intended use.

 

Article 3 As a part of the quality management system, this specification is the basic requirement for pharmaceutical production management and quality control. It aims to minimize the risks of pollution, cross-contamination, confusion and errors in the production process of pharmaceuticals, and to ensure continuous and stable production. A drug that meets the intended use and registration requirements.

 

Article 4 An enterprise shall strictly implement this Code, adhere to honesty and trustworthiness, and prohibit any false or deceptive behavior.

 

Chapter II Quality Management

 

Section 1 Principle

 

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

 

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

 

Article 7 An enterprise shall be equipped with sufficient personnel, workshops, facilities and equipment that meet the requirements to provide the necessary conditions for achieving the 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 establish a complete file system to ensure the effective operation of the system.

 

Article 9 The quality assurance system shall ensure that:

(1) The design and development 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 materials and packaging materials purchased and used are correct;

(5) The intermediate products are effectively controlled;

(6) Implementation of confirmation and verification;

(7) Conducting production, inspection, inspection and review in strict accordance with the regulations;

(8) Each batch of products may be released after being approved by the quality attorney;

(9) Appropriate measures to ensure the quality of the drug during storage, shipment and subsequent operations;

(10) Regularly check the validity and applicability of the quality assurance system in accordance with the self-inspection operation procedures.

 

Article 10 Basic requirements for quality management of pharmaceutical production:

(1) Formulating the production process, systematically reviewing and proving that it can produce products that meet the requirements in a sustainable and stable manner;

(2) The production process and major changes have been verified;

(3) Equipping the required resources, including at least:

1. Personnel with appropriate qualifications and qualified training;

2. Sufficient plant and space;

3. Applicable equipment and maintenance support;

4. Proper raw materials, packaging materials and labels;

5. Approved process procedures and operating procedures;

6. Appropriate storage and transportation conditions.

(4) The operating procedures should be formulated in an accurate and understandable language;

(5) The operator is trained to operate correctly in accordance with the operating procedures;

(6) The whole process of production shall have records, and the deviations shall be investigated and recorded;

(7) The batch record and shipping record shall be able to trace the complete history of the batch of products and keep them in a safe place for easy access;

(8) reducing the quality risks in the process of drug shipment;

(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 happening again.

 

Section III Quality Control

 

Article 11 Quality control includes the corresponding organization, file system, sampling, inspection, etc., to ensure that the materials or products complete the necessary inspection before release, to confirm that the quality meets the requirements.

 

Article 12 Basic requirements for quality control:

(1) All appropriate quality control related activities shall be completed effectively and reliably with appropriate facilities, equipment, instruments and trained personnel;

(2) There should be approved operating procedures for the sampling, inspection, inspection and stability inspection of raw and auxiliary materials, packaging materials, intermediate products, products to be packaged and finished products, and environmental monitoring if necessary to ensure compliance with this specification. Requirements

(3) Sampling raw materials, packaging materials, intermediate products, products to be packaged and finished products by authorized personnel in accordance with the prescribed methods;

(4) The inspection method shall be verified or confirmed;

(5) Sampling, inspection and inspection shall have records, and the deviation 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 recorded;

(7) The finished product of the material and the final package shall have sufficient sample to prepare for the necessary inspection or inspection; the sample packaging of the finished product shall be the same as the final package except for the over-sized finished product.

 

Section IV Quality Risk Management

 

Article 13 Quality risk management is a systematic process of assessing, controlling, communicating and reviewing quality risks by means of forward-looking or retrospective methods throughout the product life cycle.

 

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

 

Article 15 The methods, measures, forms and documents adopted in the quality risk management process shall be compatible with the level of risk.

 

Chapter III Institutions and Personnel

 

Section 1 Principle

 

Article 16 An enterprise shall establish a management institution that is compatible with the production of pharmaceuticals and has an organizational chart.

An enterprise shall establish an independent quality management department to perform its duties of quality assurance and quality control. The quality management department can set up the quality assurance department and the quality control department separately.

 

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

 

Article 18 An enterprise shall be equipped with a sufficient number of management and operational personnel with appropriate qualifications (including academic qualifications, training and practical experience), and shall clearly define the responsibilities of each department and each post. Job responsibilities must not be missed, and the duties of the cross should be clearly defined. Everyone should not take on too many responsibilities.

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

 

Article 19 Responsibilities are usually not delegated to others. If it is necessary to entrust, its responsibilities can be delegated to a qualified person with considerable qualifications.

 

Section 2 Key personnel

 

Article 20 The key personnel shall be full-time personnel 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 entitled to quality.

The person in charge of quality management and the person in charge of production management shall not concurrently serve each other. The quality management person in charge and the quality attorney can concurrently serve. Operating procedures should be established to ensure that quality attorneys perform their duties independently and are not interfered by the person in charge of the company and other personnel.

 

Article 21 Business person in charge

The person in charge of the enterprise is the main responsible person of the quality of the drug and is fully responsible for the daily management of the enterprise. In order to ensure that the company achieves the quality objectives and produces the drugs in accordance with the requirements of this specification, the person in charge of the enterprise shall be responsible for providing the necessary resources, reasonably planning, organizing and coordinating to ensure that the quality management department performs its duties independently.

 

 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 major (or intermediate professional technical title or licensed pharmacist qualification), and have at least three years of practical experience in pharmaceutical production and quality management, including at least one year of experience in pharmaceutical production management. Expertise training related to the products produced.

(2) Main responsibilities:

1. Ensure that the drugs are produced and stored in accordance with the approved technical procedures to ensure the quality of the drugs;

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

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

4. Ensure the maintenance of the plant and equipment to maintain its good operating condition;

5. Ensure that all necessary verification work is completed;

6. Ensure that production-related personnel undergo the 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 major (or intermediate professional technical title or licensed pharmacist qualification), and have at least five years of practical experience in pharmaceutical production and quality management, including at least one year of experience in drug quality management. Expertise 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 the registration;

2. Ensure that the review of the batch records is completed before the product is released;

3. Ensure that all necessary inspections are completed;

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

5. Review and approve all quality related changes;

6. Ensure that all major deviations and test results are exceeded and have been investigated and processed in a timely manner;

7. Approve and supervise the commissioned inspection;

8. Supervise the maintenance of the plant and equipment to maintain its good operating condition;

9. Ensure that all necessary validation or verification work is completed, review and approval confirmation or verification of the program and report;

10. Ensure that the self-test is completed;

11. Evaluate and approve material suppliers;

12. Ensure that all complaints related to product quality have been investigated and processed in a timely and correct manner;

13. Ensure that the product's continuous stability study plan is completed and data on stability studies are provided;

14. Ensure that product quality review analysis is completed;

15. Ensure that quality control and quality assurance personnel have passed the necessary pre-job training and continuing training, and adjust the training content according to actual needs.

 

Article 24 The person in charge of production management and the person in charge of quality management usually have the following common responsibilities:

(1) Documents for reviewing and approving product specifications and operating procedures;

(2) Supervising the health status of the plant;

(3) ensuring that key equipment has been confirmed;

(4) Ensuring that the production process is verified;

(5) Ensure that all relevant personnel of the enterprise have passed the necessary pre-job training and continuing training, and adjust the training content according to actual needs;

(6) Approving and supervising the commissioned production;

(7) Identifying and monitoring the storage conditions of materials and products;

(8) keeping records;

(9) Supervising the implementation status of this Code;

(10) Monitoring factors affecting product quality.

 

Article 25 Quality Attorney

(1) Qualification:

The quality attorney should have at least a bachelor's degree in pharmacy or related major (or intermediate professional technical title or licensed pharmacist qualification), have at least five years of practical experience in pharmaceutical production and quality management, and have engaged in drug production process control and quality inspection.

The quality attorney should have the necessary professional theoretical knowledge and be able to perform his duties independently after training related to product release.

(2) Main responsibilities:

1. Participate in quality management activities such as establishment of enterprise quality system, internal self-inspection, external quality audit, verification, adverse drug reaction report, product recall, etc.

2. To assume the responsibility of product release, to ensure that the production and inspection of each batch of released products are in compliance with relevant regulations, drug registration requirements and quality standards;

3. Before the product is released, the quality attorney must issue the product release audit record in accordance with the requirements of item 2 above and include the batch record.