【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(jí)別的產(chǎn)品受調(diào)整的控制，并相對(duì)于級(jí)別二和三而言，在設(shè)計(jì)上較為簡(jiǎn)單但對(duì)使用者幾乎沒(méi)有任何的傷害。 Examples of Class II devices:二級(jí)別產(chǎn)品舉例： Surgical drapes 外科醫(yī)用臺(tái)布 Tampons 止血棉塞 18 Medical Device cGMPs 醫(yī)療產(chǎn)品的 cGMPs Class III 等級(jí) 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(jí)別三是最嚴(yán)格的級(jí)別，三級(jí)別的產(chǎn)品是指除了一般和特殊控制外，還未有足夠的信息以確認(rèn)產(chǎn)品的安全性的產(chǎn)品。 cGMP’s Cosmetic Products美容用品的生產(chǎn)質(zhì)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(chǎn)質(zhì)量操作規(guī)范 僅是個(gè)方針 ? 生產(chǎn)者必須對(duì)產(chǎn)品的安全性負(fù)責(zé)（如不可有次品） ? 無(wú)任何有毒物質(zhì) ? 金伯利的生產(chǎn)質(zhì)量操作規(guī)范適用于產(chǎn)品的制作，儲(chǔ)存，分銷(xiāo) FDA Facility Registration Cosmetic Products 美國(guó)聯(lián)邦政府美容用品注冊(cè) ? 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(cè) ? 每個(gè)生產(chǎn)及包裝設(shè)備的注冊(cè) ? 公司名稱(chēng)，地址和產(chǎn)品名稱(chēng)的注冊(cè) 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(chǎn)品使用狀況下可引起傷害的物質(zhì) ? 有部分或完全污物 ? 在有污物情況下生產(chǎn)的 ? 集裝箱有能造成產(chǎn)品損害物質(zhì)的 Definition of Misbranded Product 錯(cuò)誤標(biāo)記產(chǎn)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(cuò)誤的標(biāo)記 ? 標(biāo)記上未印有重量和分銷(xiāo)商 ? 缺乏凈含量 ? 未確認(rèn)的顏色 26 Overview of GMP’s GMP’s總攬 ? Medical Devices 醫(yī)療產(chǎn)品 ? Cosmetics 美容產(chǎn)品 27 cGMP’s for Medical Devices醫(yī)療產(chǎn)品的最新生產(chǎn)操作規(guī)范 ? A. General Provisions 一般規(guī)定 ? B. Quality System Requirements 質(zhì)量體系要求 ? C. Design Controls 設(shè)計(jì)控制 ? D. Document Controls 文檔控制 ? E. Purchasing Controls 采購(gòu)控制 ? F. Identification and Traceability 驗(yàn)明和可追述性 ? G. Production and Process Controls 產(chǎn)品及進(jìn)程控制 ? H. Acceptance Activities 可接受性 ? I. Nonconforming Product 非確認(rèn)產(chǎn)品 ? J. Corrective and Preventive Action 糾正及預(yù)防措施 ? K. Labeling and Packaging Control 標(biāo)簽和包裝控制 ? L. Handling, Storage, Distribution, and Installation 處理，儲(chǔ)藏，分銷(xiāo)和安裝 ? M. Records 記錄 ? N. Servicing 服務(wù) ? O. Statistical Techniques 技術(shù) 28 GMP Linkage to the QMS 生產(chǎn)操作規(guī)范和質(zhì)量管理體系的聯(lián)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(guān)鍵差別？ f. 要求變化的作用？ 29 QMS/GMP Similarities 質(zhì)量管理體系和生產(chǎn)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(zhì)量管理體系是作用于符合外部和全球性的標(biāo)準(zhǔn) ? 質(zhì)量管理體系高級(jí)別的要求必須符合可調(diào)整的要求之內(nèi) 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(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(jìng)爭(zhēng)性的優(yōu)勢(shì) ? 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(píng)價(jià)混淆風(fēng)險(xiǎn)的工具 43 GMP Next Steps GMP下階段 ? Impact on North Asia ? Korea ? China ? Taiwan ? 對(duì)北亞的影響 ? 韓國(guó) ? 中國(guó) ? 臺(tái)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(kāi)始評(píng)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(wèn)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(chǎng)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(chǎng)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(chǔ)存，并用于設(shè)備的堆放，日常原料的儲(chǔ)存，衛(wèi)生的操作以及適度的清潔和維護(hù)。并通過(guò)以避免因灰塵等原因造成材料的腐蝕 ? 器具，運(yùn)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(chǔ)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., a