【正文】 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 devices are subject to General Controls as are Class II and Class III devices. 一級別的產品受調整的控制，并相對于級別二和三而言，在設計上較為簡單但對使用者幾乎沒有任何的傷害。 Examples of Class II devices:二級別產品舉例： Surgical drapes 外科醫(yī)用臺布 Tampons 止血棉塞 18 Medical Device cGMPs 醫(yī)療產品的 cGMPs Class III 等級 III Class 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. 級別三是最嚴格的級別，三級別的產品是指除了一般和特殊控制外，還未有足夠的信息以確認產品的安全性的產品。 cGMP’s Cosmetic Products美容用品的生產質量操作規(guī)范 ? cGMP?s ONLY a guideline ? Manufacturer responsible for safety of product (ie not adulterated, misbranded) ? No drug claims (implicit or explicit) can be made ? “KC GMP?s” apply to manufacturing, storage and distribution of product ? 最新生產質量操作規(guī)范 僅是個方針 ? 生產者必須對產品的安全性負責（如不可有次品） ? 無任何有毒物質 ? 金伯利的生產質量操作規(guī)范適用于產品的制作，儲存，分銷 FDA Facility Registration Cosmetic Products 美國聯邦政府美容用品注冊 ? None required by statute ? VOLUNTARY registration allowed (21CFR 710) ? Registration of each manufacturing and packaging facility ? Identify pany name, address and product name in registration ? 法規(guī)未要求的 ? 自行的注冊 ? 每個生產及包裝設備的注冊 ? 公司名稱，地址和產品名稱的注冊 Definition of Adulterated Product 次品的定義 ? Contains any poisonous or harmful substance which causes injury under remended condition of use ? Consists in whole or part of filth ? Made under filthy conditions ? Container posed of harmful substance which gets into the product ? 含有任何有污染或有害的在產品使用狀況下可引起傷害的物質 ? 有部分或完全污物 ? 在有污物情況下生產的 ? 集裝箱有能造成產品損害物質的 Definition of Misbranded Product 錯誤標記產品的定義 ? False and misleading labeling ? Failure to label w/name and address of mfg., pkg., or distributor ? Lacks content statement ? Nonpliance of required labeling ? Nonconforming colors ? 錯誤的標記 ? 標記上未印有重量和分銷商 ? 缺乏凈含量 ? 未確認的顏色 26 Overview of GMP’s GMP’s總攬 ? Medical Devices 醫(yī)療產品 ? Cosmetics 美容產品 27 cGMP’s for Medical Devices醫(yī)療產品的最新生產操作規(guī)范 ? A. General Provisions 一般規(guī)定 ? B. Quality System Requirements 質量體系要求 ? C. Design Controls 設計控制 ? D. Document Controls 文檔控制 ? E. Purchasing Controls 采購控制 ? F. Identification and Traceability 驗明和可追述性 ? G. Production and Process Controls 產品及進程控制 ? H. Acceptance Activities 可接受性 ? I. Nonconforming Product 非確認產品 ? J. Corrective and Preventive Action 糾正及預防措施 ? K. Labeling and Packaging Control 標簽和包裝控制 ? L. Handling, Storage, Distribution, and Installation 處理，儲藏，分銷和安裝 ? M. Records 記錄 ? N. Servicing 服務 ? O. Statistical Techniques 技術 28 GMP Linkage to the QMS 生產操作規(guī)范和質量管理體系的聯系 a. What are the similar requirements? b. What are the key differences? c. What is the impact of the required changes? d. 要求的相似處？ e. 關鍵差別？ f. 要求變化的作用？ 29 QMS/GMP Similarities 質量管理體系和生產操作規(guī)范的相似處 ? 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. ? 質量管理體系是作用于符合外部和全球性的標準 ? 質量管理體系高級別的要求必須符合可調整的要求之內 30 Specific requirements for GMP’s GMP’s的特殊要求 ? Complaints Process ? Design Verification amp。 41 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!!! 一切都是為了生產安全整潔的產品 ? 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 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 ? Project Management 項目管理 44 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. 產品 設計，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)質量領導 46 Questions 問題 47 Appendix A 附錄 A ? Cosmetic and Drug GMP?s ? 美容及藥品生產質量操作規(guī)范 48 Cosmetic / Drug GMP’s 美容及醫(yī)藥生產質量操作管理規(guī)范 ? Buildings and Facilities 生產場地及設備 ? 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. ? 生產場地是指用于合適尺寸，設計的美容產品的生產和儲存，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。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品的生產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，生產美容用品的設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., a