全球质量经理的培训教材ppt课件

1、Objectives 培训目的Introduction to GMPs?良好消费操作规范GMPs) 概述Why do we need GMPs我们为什么需求GMPs？When to we use GMPs?我们何时需求用到GMPs？General Overview of basic cGMP RequirementsCGMP根本要求总揽Key differences from the QMS与质量管理体系的关键区别Implementing for success胜利的方法1.Introduction to GMPs 良好消费操作规范引言GMPs defined History Applicat

2、ions GMPs 定义历史适用范围2.cGMPs Overview最新食品及药物消费质量管理规范概要North Asia Quality Managers MeetingMarch 6, 2007Taipei Taiwan 北亚质量经理睬议 2007，3，6，台北，台湾3.Current Good Manufacturing Practices (cGMP) 最新食品及药物消费质量管理规范Good Manufacturing Practices are.the current minimum guidelines for controlling the manufacturing, proc

3、essing, packing and holding of drug products to assure that the products are safe for use, are properly identified, of proper strength, and of appropriate quantity and quality.消费管理规范是指。现行是指用以控制消费，进程，包装和坚持药品的最小方针，以此确保产品固有的数量及质量，并平安的被运用。4.GMP History GMP历史Food and Drug Administration - Federal Food, D

4、rug and Cosmetic Act of 1938, as Amended: 1938年美国联邦政府食品药物管理规范规定：To protect the consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate commerce of adulterated or misbranded food, drug, devices and cosmetics.经过制止次级或被错误标志的食品，药品，设备和化装品国际贸易中的变动，以确保消费者的

5、利益不被危险性的或者带有欺骗性的标签和包装的产品所损害。5.Food and Drug Administration 食品，药品规程The U.S. Food and Drug Administration (FDA) is a public health agency that is charged with protecting American consumers by enforcing the U.S. Federal Food, Drug, and Cosmetic Act and other related public health laws. 美国食品药物管理局是经过实施美国

6、联邦政府食品药物控制及其他相关公众安康法规，以确保美国消费者安康的公众机构。6.Food and Drug Administration 食品和药物控制Basic FDA Product RequirementsSafe for intended useDrugs and devices effective for intended useNot adulterated (i.e., contains what, and only what, it is supposed to contain)Not misbranded (i.e., labeled as it should be)Manu

7、factured in compliance with applicable cGMPs美国联邦政府食品药物控制根本要求产品用途平安性药品及设备有效运用未渗入次品如产品包含成分，仅有成分等无错误标志如标签按照可行的最新食品及药品消费质量规范进展消费7.Why do we need GMPs 我们为何需求药品消费管理规范？Where is K-C going?LiabilityCompliance (FDA audits and reports)KC在哪些方面实施？职责承诺 (美国联邦政府食品药物管理局审核和报告8.K-C Direction K-C引言“A host of internal a

8、nd external challenges are driving significant change within Kimberly-Clark. Therefore, we are making changes to become a winning global health and hygiene company. (taken from the K-C Intranet GBP site) 一系列内外部的挑战正随着金伯利发生着强大的变化。因此，我们正在朝着全球领先的安康卫消费品公司而努力着。摘自KC企业内部GBP网9.K-C Expectations KC的期望Corporate

9、 Integrity and ExpectationsProduct Safety ClearancesMeets Customer RequirementsOnly Approved MaterialsProperly and Effectively PackagedAccurately Branded and LabeledCorporate Manufacturing StandardsEnsure inspection readiness企业诚信和展望产品平安性满足客户要求仅被认可的资料合理有效的包装准确的商标及标识企业消费规范平安监查预备10.Why cGMPs？为何实施cGMPs?

10、Its good businessProtect our consumersProtect our businessCustomer requirementsMaintain regulatory complianceRules for producing Safe and Clean ProductsPart of an appropriate Quality System良好的商机维护我们消费者的利益维护我们的商业时机客户要求遵守规范的承诺产品平安性和整洁度的规范适当的质量体系11.GMPs are part of an “Appropriate Quality System GMPs是特

11、有的质量体系The Kimberly-Clark Quality Management System requirements (QMS) includes all regulatory requirements for a “appropriate quality system.ISO 13485 includes all regulatory requirements for a “appropriate quality system.ISO 9001 does not include all GMP requirements金伯利质量管理体协要求指一切针对特有的质量体系而调整的要求ISO

12、13485指一切针对特有的质量体系而调整的要求ISO 9001不包含一切的GMP要求12.Legal Responsibilities 法律责任Must comply with the Federal Food, Device, Drug, and Cosmetic ActMust comply with the Fair Packaging and Labeling ActMust comply with Regulations issued under the authority of these Laws Enforced as part of the FD&C Act必需遵照美国联邦政

13、府食品，设备药物控制规程必需遵照美国公平包装标式法必需遵照由上述权威法律所签署的相关规章必需实施美国联邦政府食品药物控制规程13.When would we use GMPs? 何时运用GMPs？Production of regulated productsCustomer requirementsBusiness requirementsProtect the brand or businessProtect our C/S/C/U. 符合规那么的产品消费客户要求商业要求维护品牌和商业维护我们的 C/S/C/U14.Also known as 21 CFR 820, Part 820, c

14、GMPApplies to all medical device firmsMost Class 1 devices are exempt from design controlsSome very low risk Class 1 devices are exempt from all except complaint handling and record keeping requirements作为最新食物药品消费质量规范章程，章节820适用一切医疗产品商绝大多数级别一的产品免除设计方面的控制一些风险较小的级别一的产品可免除除了处置赞扬和坚持记录以外的其他要求FDA Quality Sy

15、stem Regulation 美国联邦政府质量体系规章15.Medical Device cGMPs 医疗设备动态药品消费管理规范Medical Device Classes:医疗设备等级Class I 等级Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I device

16、s are subject to General Controls as are Class II and Class III devices.一级别的产品受调整的控制，并相对于级别二和三而言，在设计上较为简单但对运用者几乎没有任何的损伤。一级别的产品在常规控制中和级别二三一样。Examples of Class I devices:Unscented Pads or LinersExamination glovesAdult incontinence exempt一级别产品引例：无气味的衬垫测试手套Note:Most Class I devices are exempt from the p

17、remarket notification and/or good manufacturing practices regulation.留意：大多数一级品除了先期市场告知外，都必需遵守良好的消费实际定律。16.Medical Device cGMPs 医疗产品的最新消费质量操作规范Class II 等级IIClass II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are availab

18、le to provide such assurances. In addition to complying with general controls, Class II devices are also subject to special controls. 二级别的产品是指那些在普通控制下还未足够保证平安性能及效果的情况下，并存有其他技术以更好确实保其平安性，除普通控制之外，二级别的产品还受控于特殊控制。Examples of Class II devices:二级别产品举例：Surgical drapes 外科医用台布Tampons 止血棉塞17.Medical Device cG

19、MPs 医疗产品的cGMPsClass III 等级IIIClass III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general or special controls.级别三是最严厉的级别，三级别的产品是指除了普通和特殊控制外，还未有足够的信息以确认产品的平安性的产品。Class I

20、II devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 级别三的产品通常是那些用以支持和维护人类生活，并防止发生人体损伤或潜在及不合理的损伤风险的具有本质重要性的产品。Example of Class III device: 级别三的产品举例

21、：implantable pacemaker 植入式心脏起博器 18.Medical Device Reporting (21CFR 803)Corrections, Removals and Withdrawals (21CFR 806)Labeling (21CFR 801) Electronic Records, Electronic Signatures (21CFR 11)Registration & Listing (21CFR 807)Quality System Regulation (21 CFR 820) with exemptions医疗产品报告更正，解除标注电子记录，电

22、子签名登记和名录质量体协规章含免除部分What FDA Regulations Apply? 美国联邦政府食品药物管理规定适用什么？19.CE Marking - Medical Device Directive (MDD 93/42/EEC) if the product is distributed in the European UnionDevices must meet the essential requirements in Annex I.Technical documentation is required as outlined in Annex VIICE mark is

23、 affixed to the product in accordance with the procedure described in Annex XII.CE标志-医疗产品指点，假设该产品分售到欧洲联盟产品必需符合必需的要求见附录I技术文档要求在附录VII概述CE标志必需按照附录XII中描画的进程贴上What Other Quality System Standards Apply?其他质量体系规范适用什么？20.Cosmetic Products 美容用品“Articles, other than soap, intended to be rubbed, sprinkled, or s

24、prayed on, introduced into or otherwise applied to the body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the bodys structure or function.那些除了肥皂外用于使身体清洁美观等的任何喷雾或洗涤用品，并对身体不呵斥任何的损伤。21.cGMPs Cosmetic Products美容用品的消费质量操作规范cGMPs - O

25、NLY a guidelineManufacturer responsible for safety of product (ie not adulterated, misbranded)No drug claims (implicit or explicit) can be made“KC GMPs apply to manufacturing, storage and distribution of product最新消费质量操作规范-仅是个方针消费者必需对产品的平安性担任如不可有次品无任何有毒物质金伯利的消费质量操作规范适用于产品的制造，储存，分销.FDA Facility Regist

26、rationCosmetic Products 美国联邦政府美容用品注册None required by statuteVOLUNTARY registration allowed (21CFR 710)Registration of each manufacturing and packaging facilityIdentify company name, address and product name in registration法规未要求的自行的注册每个消费及包装设备的注册公司称号，地址和产品称号的注册.Definition of Adulterated Product 次品的定义

27、Contains any poisonous or harmful substance which causes injury under recommended condition of useConsists in whole or part of filthMade under filthy conditionsContainer composed of harmful substance which gets into the product含有任何有污染或有害的在产品运用情况下可引起损伤的物质有部分或完全污物在有污物情况下消费的集装箱有能呵斥产品损害物质的.Definition of

28、 Misbranded Product 错误标志产品的定义False and misleading labelingFailure to label w/name and address of mfg., pkg., or distributorLacks net content statementNoncompliance of required labelingNonconforming colors错误的标志标志上未印有分量和分销商缺乏净含量未确认的颜色.Overview of GMPs GMPs总揽Medical Devices 医疗产品Cosmetics 美容产品26.cGMPs f

29、or Medical Devices医疗产品的最新消费操作规范A. General Provisions 普通规定B. Quality System Requirements 质量体系要求C. Design Controls 设计控制D. Document Controls 文档控制E. Purchasing Controls 采购控制F. Identification and Traceability 验明和可追述性G. Production and Process Controls 产品及进程控制H. Acceptance Activities 可接受性I. Nonconforming P

30、roduct 非确认产品J. Corrective and Preventive Action 纠正及预防措施K. Labeling and Packaging Control 标签和包装控制L. Handling, Storage, Distribution, and Installation 处置，贮藏，分销和安装M. Records 记录N. Servicing 效力O. Statistical Techniques 技术27.GMP Linkage to the QMS 消费操作规范和质量管理体系的联络What are the similar requirements?What are

31、 the key differences?What is the impact of the required changes?要求的类似处？关键差别？要求变化的作用？28.QMS/GMP Similarities 质量管理体系和消费操作规范的类似处The QMS was written to work in harmony with external standards and global formats. The QMS high level requirements fit within the specifics of regulatory requirements.质量管理体系是作

32、用于符合外部和全球性的规范质量管理体系高级别的要求必需符合可调整的要求之内29.Specific requirements for GMPs GMPs的特殊要求Complaints ProcessDesign Verification & ValidationDevice Master Record (DMR)Device History Record (DHR)Quality System RegulationElectronic RecordsProcess ValidationChange ControlsRegistrations and ApprovalsOthers赞扬方法设计认可

33、和确认产品主要记录产品历史记录质量体系规章电子记录方法确认改动控制登记和认可其他30.Any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution.任何落笔的，电子的或口头交流的关于在产品出产或分销后，对产品的阐明，质量，耐久

34、性，可靠和平安性的不完备的申诉。What is a Complaint?什么是赞扬31.Requirements are discussed in 21CFR 820.198 要求在21CFR 820.198被讨论过The regulation requires 规章要求Documented procedures 进程文档记录Timely and uniform processing 及时一致的处置Process for evaluation/investigation 评价方法Adverse event consideration (serious injury or death)不利方面的

35、思索严重的损伤或死亡Additional requirements apply to complaints alleging serious injury or death (21 CFR 803)正对严重损伤或死亡的申诉的额外要求21CFR803)What About Complaint Files? 赞扬文件32.A compilation of records containing the production history of a finished device. 记录需包含每个废品的消费历史A DHR includes DHR包含 Dates of manufacture 消费日

36、期Quantity manufactured and released 数量和消费Acceptance records 可接受记录Primary identification label 主要确认标志Device identification and lot number 产品确认和消费标号What is a DHR?DHR是什么？33.Maintained at the manufacturing site or otherwise reasonable accessible.维护消费地或合理进入Legible and complete (errors must be appropriate

37、ly corrected) 易读的和完成的错误必需适当纠正Retained for the life of the product (minimum 2 years from date of release).产品寿命需维持从消费日期起至少2年Exceptions include Management Review, Quality Audits and Supplier Audits.特殊情况包含管理检阅，质量审核和供应商审核Record Requirements 记录要求34.Additional requirementsElectronically stored must be back

38、ed upElectronically created must comply with Part 11 requirementsElectronically signed must comply with Part 11 requirementsCSV Roadmap kcc/mis/ProgramOffice/ICS/CSV/CSVRoadMap/CSVFlow/CSV%20Roadmap_frame.htm额外要求电子贮藏-必需后备电子生成-必需与11章节要求一致电子签署-必需与11章节要求一致CSV途径httpkcc/mis/ProgramOffice/ICS/CSV/CSVRoadM

39、ap/CSVFlow/CSV%20Roadmap_frame.htmElectronic Record Requirements 电子记录要求35.Design Verification and Validation, Process Validation 设计及方法确认和同意Design Verification and ValidationsMust verify design “Output meets “Input.Must validate design under normal operating conditions with production product. Design

40、 validation must Risk assessments.设计确实认和同意必需确认设计从消费和出产的一致必需在常规产品消费操作的情况下同意设计设计同意必需经过风险评价Process Validations 方法同意Where results of a process can not be verified, a process shall be validated, i.e., bioburden, cleaning, sanitization, etc. 当一种方法的结果不被查证时，36.Change Requirements 改动要求Change control process

41、for the identification, documentation, validation, or where appropriate verification, review and approval of changes before implementation. 改动控制进程是在改动实施之前，针对改动的，审阅，查证，认可随后做出相应的审批，法律批文和文档的过程。These changes include, but are not limited to: 这些改动包含以下方面但不仅限于此：Design 设计Process 进程Software 软件Cleaning 清洁Sanit

42、ization 去除干净37.GMP Controls - What needs to be in place? 什么适当的方面需求GMP控制Understand the scope, risk and regulationsAssess risks HACCPProduct History领会范围，风险及规章评价风险-HACCP 危害分析关键控制点产品历史38.Risk Assessment Scope 风险评价范围39.How do we assess GMP risks?我们如何评价GMP风险？HACCP is a proactive systematic approach to the

43、 identification, assessment of risk and severity, and control of biological, chemical, and physical hazards/contamination associated with a product, production process or practice. HACCP是一种较有体系的方法，使产品在消费实际过程中，对产品生物化学物理技艺等方面的风险及严肃性的审查及评价。 40. Why use HACCP?为何适用危害分析关键控制点Its all about making Safe and C

44、lean products and meeting Good Manufacturing Practices! 一切都是为了消费平安整洁的产品Regulatory requirements 调整要求Competitive advantage for identification of design issues early 设计版本及早确实认具有竞争性的优势Protection for product liability awards 产品审查责任的维护Learn about HACCP as a tool for assessing contamination risks 学习HACCP作为

45、评价混淆风险的工具41.HACCP for Diapers - Example42.GMP Next Steps GMP下阶段Impact on North AsiaKoreaChinaTaiwan对北亚的影响韩国中国台湾Plans for implementation 方案实施Training 培训Project Management 工程管理43.The 3 Keys to Success with GMPs GMPs胜利的三点关键Critical Start Infrastructure and SystemsAvoid Surprises Communicate and plan Ea

46、rlyProduct Design, Development, Process and Approvals开场评论-构造和体系防止不测事件-及早沟通与方案产品-设计，开展进程和认可44.Resources 资源GRSARegulatory AffairsCART (Compliance and Resource Team)Global Capability TeamsBusiness Quality Leaders规程CART资源团队全球力量团队商业质量指点45.Questions 问题46.Appendix A 附录ACosmetic and Drug GMPs美容及药品消费质量操作规范47

47、.Cosmetic / Drug GMPs 美容及医药消费质量操作管理规范Buildings and Facilities 消费场地及设备Buildings used in the manufacture or storage of cosmetics are of suitable size, design and construction to permit unobstructed placement of equipment, orderly storage of materials, sanitary operation, and proper cleaning and mainte

48、nance. Floors, walls and ceilings are constructed of smooth, easily cleanable surfaces and are kept clean and in good repair. Fixtures, ducts and pipes are installed in such a manner that drip or condensate does not contaminate cosmetic materials, utensils, cosmetic contact surfaces of equipment, or

49、 finished products in bulk. 消费场地是指用于适宜尺寸，设计的美容产品的消费和储存，并用于设备的堆放，日常原料的储存，卫生的操作以及适度的清洁和维护。地板，墙壁和天花板必需平整的建筑，并较易的可做外表清洁和良好的维修。安装物，电线以及管道等必需被合理安装，以防止有房屋渗漏景象导致机械外表，箩筐里面的废品的破损。48.Cosmetic / Drug GMPs美容及医药消费质量操作管理规范Buildings and Facilities (continued)Lighting and ventilation are sufficient for the intended

50、operation and comfort of personnel. Water supply, washing and toilet facilities, floor drainage and sewage system are adequate for sanitary operation and cleaning of facilities, equipment and utensils, as well as to satisfy employee needs and facilitate personal cleanliness. 照明以及通风必需足以使个人温馨和顺应操作水供应，

51、洗手间设备，地面排水渠道和排污系统必需足以满足卫生操作和设备清洁也必需满足雇员个人的清洁49.Cosmetic / Drug GMPs美容及医药消费质量操作管理规范Equipment 设备Equipment and utensils used in processing, holding, transferring and filling are of appropriate design, material and workmanship to prevent corrosion, buildup of material, or adulteration with lubricants, d

52、irt or sanitizing agent. Utensils, transfer piping and cosmetic contact surfaces of equipment are well-maintained and clean and are sanitized at appropriate intervals. Cleaned and sanitized portable equipment and utensils are stored and located, and cosmetic contact surfaces of equipment are covered

53、, in a manner that protects them from splash, dust or other contamination. 在处置，消费，流转用途的设备和器具必需有适当的设计，原料和工艺。并经过以防止因灰尘等缘由呵斥资料的腐蚀器具，运转的管道和美容产品的消费设备必需间隔并整洁的放置整洁的便携式设备和器具需被储存，消费美容用品的设备需被遮盖以防止灰尘等污染物50.Cosmetic / Drug GMPsPersonnelThe personnel supervising or performing the manufacture or control of cosmet

54、ics has the education, training and/or experience to perform the assigned functions. Persons coming into direct contact with cosmetic materials, finished products in bulk or cosmetic contact surfaces, to the extent necessary to prevent adulteration of cosmetic products, wear appropriate outer garmen

55、ts, gloves, hair restraints etc., and maintain adequate personal cleanliness. Consumption of food or drink, or use of tobacco is restricted to appropriately designated areas. 51.Cosmetic / Drug GMPsRaw MaterialsRaw materials and primary packaging materials are stored and handled in a manner which pr

56、events their mix-up, contamination with microorganisms or other chemicals, or decomposition from exposure to excessive heat, cold, sunlight or moisture. Containers of materials are closed, and bagged or boxed materials are stored off the floor. Containers of materials are labeled with respect to ide

57、ntity, lot identification and control status. 52.Cosmetic / Drug GMPsRaw Materials (continued)Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microorganisms or other extraneous substances to the extent necessary to prevent

58、 adulteration of finished products. Pay particular attention to materials of animal or vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microorganisms. Materials not meeting acceptance specifications are properly i

59、dentified and controlled to prevent their use in cosmetics.53.Cosmetic / Drug GMPsProductionThe equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition. Only approved materials are used. Sa

60、mples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microorganisms or chemical contaminants, and compliance with any other acceptance specification. Weighing and measuring of raw ma