【正文】 scussed 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 33 ? 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？ 34 ? 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(dāng)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(yīng)商審核 Record Requirements 記錄要求 35 ? Additional requirements ? Electronically stored – must be backed up ? Electronically created – must ply with Part 11 requirements ? Electronically signed – must ply with Part 11 requirements ? CSV Roadmap VFlow/CSV% ? 額外要求 ? 電子儲藏 必須后備 ? 電子生成 必須與 11章節(jié)要求一致 ? 電子簽署 必須與 11章節(jié)要求一致 ? CSV路徑VFlow/CSV% Electronic Record Requirements 電子記錄要求 36 Design Verification and Validation, Process Validation 設(shè)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(shè)計的確認和批準 ? 必須確認設(shè)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(shè)計 ? 設(shè)計批準必須經(jīng)過風(fēng)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(dāng) 一種方法的結(jié)果不被查證時， 37 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(yīng)的審批，法律批文和文檔的過程。 41 Why use HACCP? 為何適用危害分析關(guān)鍵控制點 It’s all about making Safe and Clean products and meeting Good Manufacturing Practices!!! 一切都是為了生產(chǎn)安全整潔的產(chǎn)品 ? Regulatory requirements 調(diào)整要求 ? Competitive advantage for identification of design issues early 設(shè)計版本及早的確認具有競爭性的優(yōu)勢 ? Protection for product liability awards 產(chǎn)品審查責(zé)任的保護 ? Learn about HACCP as a tool for assessing contamination risks 學(xué)習(xí) HACCP作為評價混淆風(fēng)險的工具 43 GMP Next Steps GMP下階段 ? Impact on North Asia ? Korea ? China ? Taiwan ? 對北亞的影響 ? 韓國 ? 中國 ? 臺灣 ? Plans for implementation 計劃實施 ? Training 培訓(xùn) ? Project Management 項目管理 44 The 3 Keys to Success with GMP’s GMP’s成功的三點關(guān)鍵 1. Critical Start – Infrastructure and Systems 2. Avoid Surprises – Communicate and plan Early 3. Product – Design, Development, Process and Approvals 4. 開始評論 構(gòu)造和體系 5. 避免意外事件 及早溝通與計劃 6. 產(chǎn)品 設(shè)計，發(fā)展進程和認可 45 Resources 資源 ? GRSA ? Regulatory Affairs ? CART (Compliance and Resource Team) ? Global Capability Teams ? Business Quality Leaders ? 規(guī)程 ? CART（資源團隊） ? 全球力量團隊 ? 商業(yè)質(zhì)量領(lǐng)導(dǎo) 46 Questions 問題 47 Appendix A 附錄 A ? Cosmetic and Drug GMP?s ? 美容及藥品生產(chǎn)質(zhì)量操作規(guī)范 48 Cosmetic / Drug GMP’s 美容及醫(yī)藥生產(chǎn)質(zhì)量操作管理規(guī)范 ? Buildings and Facilities 生產(chǎn)場地及設(shè)備 ? 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 maintenance. ? 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 finished products in bulk. ? 生產(chǎn)場地是指用于合適尺寸，設(shè)計的美容產(chǎn)品的生產(chǎn)和儲存，并用于設(shè)備的堆放，日常原料的儲存，衛(wèi)生的操作以及適度的清潔和維護。 ? 裝置物，電線以及管道等必須被合理安裝，以避免有房屋滲漏現(xiàn)象導(dǎo)致機械表面，籮筐里面的成品的破損。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(shè)備必須間隔并整潔的放置 ? 整潔的便攜式設(shè)備和器具需被儲存，生產(chǎn)美容用品的設(shè)備需被遮蓋以避免灰塵等污染物 51 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. 52 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. 53 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 vegetabl