【正文】 Management Responsibility Quality Policy Management with Executive responsibility establishes policy, objectives and mitment to quality. Management with Executive responsibility ensures quality policy is understood, implemented, and maintained throughout the anization. Organization Establish and maintain adequate anizational structure Responsibility Authority Resources Management Representative 67 Medical Device cGMPs Subpart B – Quality System Requirements Management Review Management with Executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals. Quality Planning Quality Plan Quality Practices Resources Activities Established how the plan will be met Quality System Procedures Procedures Outline of Structure 167。 16 Medical Device cGMPs 醫(yī)療產(chǎn)品的最新生產(chǎn)質(zhì)量操作規(guī)范 Class II 等級 II Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to plying with general controls, Class II devices are also subject to special controls. 二級別的產(chǎn)品是指那些在一般控制下還未足夠保證安全性能及效果的情況下，并存有其他技術(shù)以更好的確保其安全性，除一般控制之外，二級別的產(chǎn)品還受控于特殊控制。 4 GMP History GMP歷史 Food and Drug Administration Federal Food, Drug and Cosmetic Act of 1938, as Amended: 1938年美國聯(lián)邦政府食品藥物管理規(guī)范規(guī)定： To protect the consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate merce of adulterated or misbranded food, drug, devices and 次級或被錯誤標記的食品，藥品，設備和化妝品國際貿(mào)易中的變動，以確保消費者的利益不被危險性的或者帶有欺騙性的標簽和包裝的產(chǎn)品所侵害。 What is a Complaint?什么是投訴 31 ? Requirements are discussed in 21CFR 要求在 21CFR ? The regulation requires 規(guī)章要求 ? Documented procedures 進程文檔記錄 ? Timely and uniform processing 及時一致的處理 ? Process for evaluation/investigation 評估方法 ? Adverse event consideration (serious injury or death)不利方面的考慮（嚴重的損傷或死亡） ? Additional requirements apply to plaints alleging serious injury or death (21 CFR 803) 正對嚴重損傷或死亡的申訴的額外要求（ 21CFR803) What About Complaint Files? 投訴文件 32 ? A pilation of records containing the production history of a finished device. 記錄需包含每個成品的生產(chǎn)歷史 ? A DHR includes DHR包含 ? Dates of manufacture 生產(chǎn)日期 ? Quantity manufactured and released 數(shù)量和生產(chǎn) ? Acceptance records 可接受記錄 ? Primary identification label 主要確認標記 ? Device identification and lot number 產(chǎn)品確認和生產(chǎn)標號 What is a DHR?DHR是什么？ 33 ? Maintained at the manufacturing site or otherwise reasonable ? Legible and plete (errors must be appropriately corrected) 易讀的和完成的（錯誤必須適當糾正） ? Retained for the life of the product (minimum 2 years from date of release).產(chǎn)品壽命需維持從生產(chǎn)日期起至少 2年） ? Exceptions include Management Review, Quality Audits and Supplier ，質(zhì)量審核和供應商審核 Record Requirements 記錄要求 34 Electronic Record Requirements 電子記錄要求 35 Design Verification and Validation, Process Validation 設計及方法確認和批準 ? Design Verification and Validations ? Must verify design “Output” meets “Input”. ? Must validate design under normal operating conditions with production product. ? Design validation must Risk assessments. ? 設計的確認和批準 ? 必須確認設計從生產(chǎn)和出產(chǎn)的一致 ? 必須在常規(guī)產(chǎn)品生產(chǎn)操作的情況下批準設計 ? 設計批準必須經(jīng)過風險評估 ? Process Validations 方法批準 ? Where results of a process can not be verified, a process shall be validated, ., bioburden, cleaning, sanitization, etc. 當 一種方法的結(jié)果不被查證時， 36 Change Requirements 改動要求 Change control process for the identification, documentation, validation, or where appropriate verification, review and approval of changes before implementation. 改變控制進程是在改變實施之前，針對改變的，審閱，查證，認可隨后做出相應的審批，法律批文和文檔的過程。 Purchasing Controls Procedures for ensuring received product services conform to specified requirements. Evaluations (suppliers, contractors, consultants) Establish and maintain requirements ? Evaluate select on basis of meeting requirements, document evaluation ? Define control based on evaluation results ? Establish maintain records of acceptable suppliers 72 Medical Device cGMPs Subpart E – Purchasing Controls 167。并通過以避免因灰塵等原因造成材料的腐蝕 ? 器具，運轉(zhuǎn)的管道和美容產(chǎn)品的生產(chǎn)設備必須間隔并整潔的放置 ? 整潔的便攜式設備和器具需被儲存，生產(chǎn)美容用品的設備需被遮蓋以避免灰塵等污染物 50 Cosmetic / Drug GMP’s ? Personnel ? The personnel supervising or performing the manufacture or control of cosmetics has the education, training and/or experience to perform the assigned functions. ? Persons ing 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 garments, 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 GMP’s ? Raw Materials ? Raw materials and primary packaging materials are stored and handled in a manner which prevents their mixup, contamination with microanisms or other chemicals, or deposition 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 identity, lot identification and control status. 52 Cosmetic / Drug GMP’s ? Raw Materials (continued) ? Materials are sampled and tested or examined in conformance with procedures assuring the absence of contamination with filth, microanisms or other extraneous substances to the extent necessary to prevent 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 mic