【文章內容簡介】 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。 These changes include, but are not limited to: 這些改變包含以下方面但不僅限于此： ? Design 設計 ? Process 進程 ? Software 軟件 ? Cleaning 清潔 ? Sanitization 清除干凈 37 GMP Controls What needs to be in place? 什么適當?shù)姆矫嫘枰?GMP控制 ? Understand the scope, risk and regulations ? Assess risks – HACCP ? Product History ? 領會范圍，風險及規(guī)章 ? 評估風險 HACCP 危害分析關鍵控制點 ? 產(chǎn)品歷史 38 Risk Assessment Scope 風險評估范圍 39 How do we assess GMP risks? 我們如何評估 GMP風險？ HACCP is a proactive systematic approach to the identification, assessment of risk and severity, and control of biological, chemical, and physical hazards/contamination associated with a product, production process or practice. HACCP是一種較有體系的方法，使產(chǎn)品在生產(chǎn)實踐過程中，對產(chǎn)品生物化學物理技能等方面的風險及嚴肅性的審查及評估。 40 Why use HACCP? 為何適用危害分析關鍵控制點 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 調整要求 ? Competitive advantage for identification of design issues early 設計版本及早的確認具有競爭性的優(yōu)勢 ? Protection for product liability awards 產(chǎn)品審查責任的保護 ? Learn about HACCP as a tool for assessing contamination risks 學習 HACCP作為評價混淆風險的工具 41 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 ? Project Management 項目管理 43 The 3 Keys to Success with GMP’s GMP’s成功的三點關鍵 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 構造和體系 5. 避免意外事件 及早溝通與計劃 6. 產(chǎn)品 設計，發(fā)展進程和認可 44 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)質量領導 45 Questions 問題 46 Appendix A 附錄 A ? Cosmetic and Drug GMP?s ? 美容及藥品生產(chǎn)質量操作規(guī)范 47 Cosmetic / Drug GMP’s 美容及醫(yī)藥生產(chǎn)質量操作管理規(guī)范 ? Buildings and Facilities 生產(chǎn)場地及設備 ? 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，設計的美容產(chǎn)品的生產(chǎn)和儲存，并用于設備的堆放，日常原料的儲存，衛(wèi)生的操作以及適度的清潔和維護。 ? 地板，墻壁和天花板必須平整的建筑，并較易的可做表面清潔和良好的維修。 ? 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)象導致機械表面，籮筐里面的成品的破損。 48 Cosmetic / Drug GMP’s美容及醫(yī)藥生產(chǎn)質量操作管理規(guī)范 ? Buildings and Facilities (continued) ? Lighting and ventilation are sufficient for the intended operation and fort 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. ? 照明以及通風必須足以使個人舒適和適應操作 ? 水供給，洗手間設備，地面排水渠道和排污系統(tǒng)必須足以滿足衛(wèi)生操作和設備清潔也必須滿足雇員個人的清潔 49 Cosmetic / Drug GMP’s美容及醫(yī)藥生產(chǎn)質量操作管理規(guī)范 ? Equipment 設備 ? 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, dirt or sanitizing agent. ? Utensils, transfer piping and cosmetic contact surfaces of equipment are wellmaintained 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, in a manner that protects them from splash, dust or other contamination. ? 在處理，生產(chǎn)，流轉用途的設備和器具必須有適當?shù)脑O計，原料和工藝。并通過以避免因灰塵等原因造成材料的腐蝕 ? 器具，運轉的管道和美容產(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 Co