1、http:/ CFDAConstructed and Maintained by the Information Center of SFDA第 1 页 共 53 页Good Manufacturing Practice for Drugs (2010 Revision)(MOHDecree No. 79)The Good Manufacturing Practice for Drugs (2010 Revision), adopted at the executive meeting of the Ministry ofHealth onOctober 19,2010, is herebyp
2、romulgated andshall go into effectas of March 1, 2011.ChenZhuMinister of MOHJanuary17, 2011GoodManufacturingPractice(GMP)forDrugsChapter1GeneralProvisionsArticle 1: These provisions of Good Manufacturing Practice (GMP) for Drugs, in accordance with the DrugAdministration Law of the Peoples Republic
3、of China and the Regulations for Implementation of the DrugAdministration Law of the Peoples Republic of China, are enacted to regulate the manufacturing and qualitymanagement ofDrugs.Article2: The manufacturer should establish a quality management system. The system should cover all factorsthat inf
4、luence the quality of drugs, including all organized and planned activities with the objective of ensuring thatthe drugs are ofthe quality requiredfor their intendeduse.Article3: GMP, as part of the quality management system, is the basic requirement of production and qualitycontrol of drugs, to ens
5、ure the products are consistently manufactured in accordance with the registrationrequirements, and are suitable for their intended use, by minimizing the risks of contamination, cross-contaminationandmixupsor errors in manufacturingprocess.Article 4: The manufacturer should strictly implement GMP w
6、ith integrity. Any falsification and fraud isforbidden. Chapter2QualityManagementhttp:/ CFDAConstructed and Maintained by the Information Center of SFDA第 2 页 共 53 页Section1PrincipleArticle5:The manufacturer should establish a quality objective to meet quality management requirements so thatall regis
7、tration requirements related to drug safety, efficacy and quality are systematically implemented throughoutthe entire process of production, control, product release, storage and distribution, to ensure that the products aremanufacturedin accordance with the registration requirements, andare suitabl
8、e for their intendeduse.Article6: The attainment of the quality objective is the responsibility of senior management and requires theparticipation and commitment by staff at all levels within the manufacturer, by the manufacturers suppliers and bythe distributors.Article7: The manufacturer should be
9、 adequately resourced with competent personnel, suitable and sufficientpremises, equipment andfacilities for achieving its quality objective.Section2QualityAssuranceArticle8: Quality Assurance is a part of the quality management system. The manufacturer should establish theQualityAssurancesystem wit
10、h the support of a complete documentation system to ensureits effective operation.Article9:The system of QualityAssuranceshouldensurethat:1.Drugs are designed anddevelopedin a waythat takes account of the requirements of GMP.2.Production andquality control operationsare in compliance with GMP.3.Mana
11、gerial responsibilities are clearly specified.4.Arrangements are made for thepurchaseand useof the correctstarting andpackaging materials.5.All necessarycontrols onintermediate products areeffectively carriedout.6.Qualifications andvalidations arecarried out.7.Drugs are correctly processed,checked,
12、tested,and verified,accordingto the definedprocedures.8.Each batchof products is notreleased beforethe approval ofthe Qualified Person.9.Satisfactory arrangements exist to ensurethat the drugs are stored,distributed andsubsequently handled.10. Self-inspection is regularly carried out to appraise the
13、 effectiveness and applicability of the Quality Assurancesystem, accordingto the procedures.Article10:The basic requirements of production and quality control are that:http:/ CFDAConstructed and Maintained by the Information Center of SFDA第 3 页 共 53 页1.All manufacturing processes are clearly defined
14、, systematically reviewed and shown to be capable of consistentlymanufacturingdrugs of the requiredquality andcomplying with their specifications.2.Steps of manufacturing processesandsignificant changes to the process arevalidated.3.All necessaryresourcesare provided including:1)Appropriately qualif
15、ied andtrained personnel;2)Adequate premises andspace;3) Suitable equipment andservices;4) Correct starting materials, packaging materials andlabels;5)Approved master manufacturing documents andoperationprocedures;6) Suitable storage andtransport.4.Instructions andprocedures are written in clearand
16、unambiguous language.5.Operators are trainedto carry out procedures correctly.6. Records should be made during the entire manufacture and any deviations are investigated and recordedaccordingly.7. Records of manufacture and distribution, which enable the complete history of a batch to be traced, are
17、 retainedin acomprehensible and accessible form.8.The distribution of theproducts minimizes anyrisk to their quality.9.Asystem is available to recall anybatchof product, from sale or supply.10. Complaints about marketed products are examined, the causes of quality defects investigated and appropriat
18、emeasurestaken inrespect of the defective products andto prevent reoccurrence.Section3QualityControlArticle11:Quality Control is concernedwith organization anddocumentation, andwith sampling, testing and etc.,which ensure that the necessary tests are actually carried out and that materials or produc
19、ts are not released, untiltheir quality hasbeenjudged to be satisfactory.Article12:The basic requirements of Quality Control arethat:http:/ CFDAConstructed and Maintained by the Information Center of SFDA第 4 页 共 53 页1. Adequate facilities, equipment, instruments and trained personnel are resourced,
20、to ensure the related qualitycontrol activities are doneeffectively andreliably.2. Approved procedures are available for sampling, inspection and testing starting materials, packaging materials,intermediate, bulk, and finished products, and stability study, and where appropriate for monitoring envir
21、onmentalconditions,to ensurethe compliancewith GMP.3. Samples of starting materials, packaging materials, intermediate, bulk and finished products are taken byauthorized personnel with approved methods.4.Testingmethods are validated orverified.5.Records are made for sampling, inspectingandtesting.An
22、y deviations are investigated andrecorded.6. Records are made of the results of inspection and that testing of materials, intermediate, bulk, and finishedproducts is formally assessed against specification.7. Sufficient reference samples of starting materials and finished products are retained to pe
23、rmit future inspectionand testing of the product when necessary, and that the finished product is retained in its final package unlessexceptionally large packages are produced.Section4 QualityRiskManagementArticle 13: Quality risk management is a systematic process for the assessment, control, commu
24、nication andreview of the risk to quality throughout the entire product life cycle. It can be applied both proactively andretrospectively.Article14: The evaluation of the risk to quality is based on scientific knowledge and experience, to ensure thequality of products.Article 15: The level of effort
25、, formality and documentation of the quality risk management process iscommensurate with the level of risk.Chapter3 OrganizationandPersonnelSection1 PrincipleArticle 16: The manufacturer should establish a management structure and have an organization chart. Thequality management department should b
26、e independent from other departments to carry out responsibilities ofhttp:/ CFDAConstructed and Maintained by the Information Center of SFDA第 5 页 共 53 页Quality Assurance and Quality Control. The quality management department can be structured into the qualityassurancedepartment andthe quality contro
27、l department separately.Article17:The quality management department should participate in all quality related activities, and review allGMP related documents. The responsibilities of quality management personnel are not permitted to be delegated topersonnel of otherdepartments.Article 18: The manufa
28、cturer should have an adequate number of managerial and operating personnel withappropriate qualifications (with respect to, including education, training, and practical experience). Theresponsibilities of each department and each position should be clearly specified. There should be no gaps orunexp
29、lained overlaps in the responsibilities. The responsibilities placed on any one individual should not beextensive.All personnel should be fully aware of and understand their responsibilities, be familiar with related requirements,andreceive necessary training, includinginitial training andcontinuing
30、training.Article19:Duties normally should not be delegated to other personnel. If deemed necessary, the duties can onlybedelegated to designated deputies ofa satisfactory qualificationlevel.Section2 KeyPersonnelArticle20: Key posts should be occupied by full-time personnel, which should at least inc
31、lude the heads of themanufacturer,production management, quality management, andthe Qualified Person.The heads of production and quality management must be independent from each other. The head of the qualitymanagement and the Qualified Person can be the same person. Procedures should be established
32、 to ensure theindependence of the Qualified Person for fulfilling responsibilities, without interference from the head of themanufactureror other personnel.Article21:The headof the manufacturerThe head of the manufacturer is principally liable for product quality and routine operation. In order to a
33、chieve themanufacturers quality objective and compliance with GMP, the head of the manufacturer should provide necessaryresources, make appropriate plan, organization and coordination, and ensure that the quality managementdepartment can fulfill its responsibilities independently.Article22:The heado
34、f production management1. Qualification: The head of production management should, at a minimum, possess a college degree inpharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a pharmacistslicense), with at least three years of practical experience i
35、n pharmaceutical production and quality management,among which at least one year in production management, with necessary training relating to the products beingmanufactured.http:/ CFDAConstructed and Maintained by the Information Center of SFDA第 6 页 共 53 页2.Main responsibilities:1) To ensure that p
36、roducts are produced and stored according to approved master manufacturing documents in orderto obtainthe requiredquality;2)Toensurestrict implementation of theprocedures relating to production operations;3) To ensure that the batch records of processing and packaging are evaluated and signed by a d
37、esignated personbeforetheyare sent to the quality management department;4)Toensurethat the premises andequipment are maintained andservicedto function in asoundoperating state;5)Toensurethat the necessaryvalidations are done;6) To ensure that required initial and continuing training of personnel in
38、production is carried out and adaptedaccordingto need.Article23:The headof quality management1. Qualification: The head of the quality management should, at a minimum, possess a college degree inpharmaceutical or relevant specialties (or with an intermediate professional technique certificate or a p
39、harmacistslicense), with at least five years of practical experience in pharmaceutical production and quality management,among which at least one year in quality management, with necessary training relating to the products beingmanufactured.2.Main responsibilities:1) To ensure that all starting mate
40、rials, packaging materials, intermediate, bulk and finished products meet theregistration requirements andspecifications;2)Toensurethat the batch recordsarereviewed beforeproduct release;3)Toensurethat all necessarytesting is carried out;4)Toapprove specifications, sampling instructions, testing met
41、hods andotherquality management procedures;5)Toreview andapprove all quality related changes;6)Toensureall significant deviations and out-of-specificationresults aretimely investigatedand handled;7)Toapprove andmonitor anycontract analysis;8)Tocheckthemaintenance ofpremises andequipment forthe purpo
42、seof maintaining a soundoperating state;http:/ CFDAConstructed and Maintained by the Information Center of SFDA第 7 页 共 53 页9)Toensure the necessary qualifications or validations are done appropriately, and to review and approve validationprotocolsandreports;10)Toensure self-inspection is done;11)Toa
43、ssess andapprove material suppliers;12)Toensure all quality related complaints are timely andproperlyinvestigated andhandled;13)Toensure the implementation of on-goingstability studyand make the stability dataavailable;14)Toensure that the product quality reviews aredone;15) To ensure that the neces
44、sary initial and continuing training of personnel in Quality Control and QualityAssuranceis carried out andadaptedaccordingto need.Article24: The heads of production and quality management generally have some shared, or jointly exercised,responsibilities relatingto quality,including:1.The review and
45、approval of master manufacturing documents, procedures,etc;2.The monitoring ofmanufacturingenvironment and planthygiene;3.Ensuring the critical equipment hasbeenqualified;4.Ensuring the completion ofmanufacturingprocessvalidation;5. Ensuring the required initial and continuing training of all relate
46、d personnel of the manufacturer is carried outandadaptedaccordingto need;6.The approval andmonitoringof contract manufacturers;7.The designation andmonitoring ofstorage conditions formaterials andproducts;8.The retention ofrecords;9.The monitoring ofcompliancewith GMP;10.Themonitoring of the factors
47、 that may affect product quality.Article25:Qualified Person1. Qualification: The Qualified Person should, at a minimum, possess a college degree in pharmaceutical or relevantspecialties (or with an intermediate professional technique certificate or a pharmacists license), with at least fivehttp:/ CF
48、DAConstructed and Maintained by the Information Center of SFDA第 8 页 共 53 页years of practical experience in pharmaceutical production and quality management, with work experience inin-processcontrol andquality testing.The Qualified Person should possess necessary theoretical knowledge in relevant specialties，be trained in productrelease soas to fulfill its responsibilities independently.2.Main responsibilities:1) To participate in quality management activities such as establishment of the quality system, self-inspection,external quality audit, validation, adve
