版GMP英文版官方.docx

1、版GMP英文版官方Good Manufacturing Practice for Drugs (2010 Revision)( MOH Decree No. 79 )The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry of Health on October 19, 2010, is hereby promulgated and shall go into effect as of March 1, 2011.Chen Zhu Mi

2、nister of MOH January 17, 2011Good Manufacturing Practice (GMP) for DrugsChapter 1 General ProvisionsArticle 1:These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the Drug Administration Law of the Peoples Republic of China and the Regulations for Implementation of th

3、e Drug Administration Law of the Peoples Republic of China, are enacted to regulate the manufacturing and quality management of Drugs.Article 2:The manufacturer should establish a quality management system. The system should cover all factors that influence the quality of drugs, including all organi

4、zed and planned activities with the objective of ensuring that the drugs are of the quality required for their intended use.Article 3:GMP, as part of the quality management system, is the basic requirement of production and quality control of drugs, to ensure the products are consistently manufactur

5、ed in accordance with the registration requirements, and are suitable for their intended use, by minimizing the risks of contamination, cross-contamination and mixups or errors in manufacturing process.Article 4:The manufacturer should strictly implement GMP with integrity. Any falsification and fra

6、ud is forbidden.Chapter 2 Quality ManagementSection 1 PrincipleArticle 5:The manufacturer should establish a quality objective to meet quality management requirements so that all registration requirements related to drug safety, efficacy and quality are systematically implemented throughout the enti

7、re process of production, control, product release, storage and distribution, to ensure that the products are manufactured in accordance with the registration requirements, and are suitable for their intended use.Article 6:The attainment of the quality objective is the responsibility of senior manag

8、ement and requires the participation and commitment by staff at all levels within the manufacturer, by the manufacturers suppliers and by the distributors.Article 7:The manufacturer should be adequately resourced with competent personnel, suitable and sufficient premises, equipment and facilities fo

9、r achieving its quality objective.Section 2 Quality AssuranceArticle 8:Quality Assurance is a part of the quality management system. The manufacturer should establish the Quality Assurance system with the support of a complete documentation system to ensure its effective operation.Article 9:The syst

10、em of Quality Assurance should ensure that:1.Drugs are designed and developed in a way that takes account of the requirements of GMP.2.Production and quality control operations are in compliance with GMP.3.Managerial responsibilities are clearly specified.4.Arrangements are made for the purchase and

11、 use of the correct starting and packaging materials.5.All necessary controls on intermediate products are effectively carried out.6.Qualifications and validations are carried out.7.Drugs are correctly processed, checked, tested, and verified, according to the defined procedures.8.Each batch of prod

12、ucts is not released before the approval of the Qualified Person.9.Satisfactory arrangements exist to ensure that the drugs are stored, distributed and subsequently handled.10.Self-inspection is regularly carried out to appraise the effectiveness and applicability of the Quality Assurance system, ac

13、cording to the procedures.Article 10:The basic requirements of production and quality control are that:1.All manufacturing processes are clearly defined, systematically reviewed and shown to be capable of consistently manufacturing drugs of the required quality and complying with their specification

14、s.2.Steps of manufacturing processes and significant changes to the process are validated.3.All necessary resources are provided including:1)Appropriately qualified and trained personnel;2)Adequate premises and space;3)Suitable equipment and services;4)Correct starting materials, packaging materials

15、 and labels;5)Approved master manufacturing documents and operation procedures;6)Suitable storage and transport.4.Instructions and procedures are written in clear and unambiguous language.5.Operators are trained to carry out procedures correctly.6.Records should be made during the entire manufacture

16、 and any deviations are investigated and recorded accordingly.7.Records of manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form.8.The distribution of the products minimizes any risk to their quality.9.A system i

17、s available to recall any batch of product, from sale or supply.10.Complaints about marketed products are examined, the causes of quality defects investigated and appropriate measures taken in respect of the defective products and to prevent reoccurrence.Section 3 Quality ControlArticle 11:Quality C

18、ontrol is concerned with organization and documentation, and with sampling, testing and etc., which ensure that the necessary tests are actually carried out and that materials or products are not released, until their quality has been judged to be satisfactory.Article 12:The basic requirements of Qu

19、ality Control are that:1.Adequate facilities, equipment, instruments and trained personnel are resourced, to ensure the related quality control activities are done effectively and reliably.2.Approved procedures are available for sampling, inspection and testing starting materials, packaging material

20、s, intermediate, bulk, and finished products, and stability study, and where appropriate for monitoring environmental conditions, to ensure the compliance with GMP.3.Samples of starting materials, packaging materials, intermediate, bulk and finished products are taken by authorized personnel with ap

21、proved methods.4.Testing methods are validated or verified.5.Records are made for sampling, inspecting and testing. Any deviations are investigated and recorded.6.Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finished products is formally assess

22、ed against specification.7.Sufficient reference samples of starting materials and finished products are retained to permit future inspection and testing of the product when necessary, and that the finished product is retained in its final package unless exceptionally large packages are produced.Sect

23、ion 4 Quality Risk ManagementArticle 13:Quality risk management is a systematic process for the assessment, control, communication and review of the risk to quality throughout the entire product life cycle. It can be applied both proactively and retrospectively.Article 14:The evaluation of the risk

24、to quality is based on scientific knowledge and experience, to ensure the quality of products.Article 15:The level of effort, formality and documentation of the quality risk management process is commensurate with the level of risk.Chapter 3 Organization and Personnel Section 1 PrincipleArticle 16:T

25、he manufacturer should establish a management structure and have an organization chart. The quality management department should be independent from other departments to carry out responsibilities of Quality Assurance and Quality Control. The quality management department can be structured into the

26、quality assurance department and the quality control department separately.Article 17:The quality management department should participate in all quality related activities, and review all GMP related documents. The responsibilities of quality management personnel are not permitted to be delegated t

27、o personnel of other departments.Article 18:The manufacturer should have an adequate number of managerial and operating personnel with appropriate qualifications (with respect to, including education, training, and practical experience). The responsibilities of each department and each position shou

28、ld be clearly specified. There should be no gaps or unexplained overlaps in the responsibilities. The responsibilities placed on any one individual should not be extensive.All personnel should be fully aware of and understand their responsibilities, be familiar with related requirements, and receive

29、 necessary training, including initial training and continuing training.Article 19:Duties normally should not be delegated to other personnel. If deemed necessary, the duties can only be delegated to designated deputies of a satisfactory qualification level.Section 2 Key PersonnelArticle 20:Key posts should be occupied by full-time personnel, which should at least include the heads of the manufacturer, production management, quality management, and the Qualified Person.The heads of production and quality management must be independent from each othe