【文章內(nèi)容簡介】 不利方面的考慮（嚴(yán)重的損傷或死亡） ? Additional requirements apply to plaints alleging serious injury or death (21 CFR 803) 正對嚴(yán)重?fù)p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(rèn)標(biāo)記 ? Device identification and lot number 產(chǎn)品確認(rèn)和生產(chǎn)標(biāo)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(jì)及方法確認(rèn)和批準(zhǔn) ? 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(jì)的確認(rèn)和批準(zhǔn) ? 必須確認(rèn)設(shè)計(jì)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(zhǔn)設(shè)計(jì) ? 設(shè)計(jì)批準(zhǔn)必須經(jīng)過風(fēng)險評估 ? Process Validations 方法批準(zhǔn) ? 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(jìn)程是在改變實(shí)施之前，針對改變的，審閱，查證，認(rèn)可隨后做出相應(yīng)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(shè)計(jì) ? Process 進(jìn)程 ? Software 軟件 ? Cleaning 清潔 ? Sanitization 清除干凈 38 GMP Controls What needs to be in place? 什么適當(dāng)?shù)姆矫嫘枰?GMP控制 ? Understand the scope, risk and regulations ? Assess risks – HACCP ? Product History ? 領(lǐng)會范圍，風(fēng)險及規(guī)章 ? 評估風(fēng)險 HACCP 危害分析關(guān)鍵控制點(diǎn) ? 產(chǎn)品歷史 39 Risk Assessment Scope 風(fēng)險評估范圍 40 How do we assess GMP risks? 我們?nèi)绾卧u估 GMP風(fēng)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(shí)踐過程中，對產(chǎn)品生物化學(xué)物理技能等方面的風(fēng)險及嚴(yán)肅性的審查及評估。 41 Why use HACCP? 為何適用危害分析關(guān)鍵控制點(diǎn) 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(jì)版本及早的確認(rèn)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(hù) ? 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(jì)劃實(shí)施 ? Training 培訓(xùn) ? Project Management 項(xiàng)目管理 44 The 3 Keys to Success with GMP’s GMP’s成功的三點(diǎn)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(jì)劃 6. 產(chǎn)品 設(shè)計(jì)，發(fā)展進(jìn)程和認(rèn)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(tuán)隊(duì)） ? 全球力量團(tuán)隊(duì) ? 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(jì)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(hù)。 ? 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(dǎo)致機(jī)械表面，籮筐里面的成品的破損。 49 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 (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(fēng)必須足以使個人舒適和適應(yīng)操作 ? 水供給，洗手間設(shè)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(shè)備清潔也必須滿足雇員個人的清潔 50 Cosmetic / Drug GMP’s美容及醫(yī)藥生產(chǎn)質(zhì)量操作管理規(guī)范 ? Equipment 設(shè)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 u