【正文】 ? Registration Listing (21CFR 807) ? Quality System Regulation (21 CFR 820) with exemptions ? 醫(yī)療產(chǎn)品報(bào)告 ? 更正，解除 ? 標(biāo)注 ? 電子記錄，電子簽名 ? 登記和名錄 ? 質(zhì)量體協(xié)規(guī)章（含免除部分） What FDA Regulations Apply? 美國聯(lián)邦政府食品藥物管理規(guī)定適用什么？ 19 ? CE Marking Medical Device Directive (MDD 93/42/EEC) if the product is distributed in the European Union ? Devices must meet the essential requirements in Annex I. ? Technical documentation is required as outlined in Annex VII ? CE mark is affixed to the product in accordance with the procedure described in Annex XII. ? CE標(biāo)記 醫(yī)療產(chǎn)品指導(dǎo)，若該產(chǎn)品分售到歐洲聯(lián)盟 ? 產(chǎn)品必須符合必須的要求（見附錄 I） ? 技術(shù)文檔要求在附錄 VII概述 ? CE標(biāo)記必須按照附錄 XII中描述的進(jìn)程貼上 What Other Quality System Standards Apply?其他質(zhì)量體系標(biāo)準(zhǔn)適用什么？ 20 Cosmetic Products 美容用品 “ Articles, other than soap, intended to be rubbed, sprinkled, or sprayed on, introduced into or otherwise applied to the body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body?s structure or function.” 那些除了肥皂外用于使身體清潔美觀等的任何噴霧或洗滌用品，并對身體不造成任何的傷害。 40 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(xiǎn)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(jì)劃實(shí)施 ? Training 培訓(xùn) ? Project Management 項(xiàng)目管理 43 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 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(tuán)隊(duì)） ? 全球力量團(tuán)隊(duì) ? 商業(yè)質(zhì)量領(lǐng)導(dǎo) 45 Questions 問題 46 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 47 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)。并通過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 50 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. 51 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. 52 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 vegetable origin and those used in the manufacture of cosmetics by cold processing methods with respect to contamination with filth or microanisms. ? Materials not meeting acceptance specifications are properly identified and controlled to prevent their use in cosmetics. 53 Cosmetic / Drug GMP’s ? Production ? The equipment for processing, transfer and filling the utensils, and the containers for holding raw and bulk materials are clean, in good repair and in sanitary condition. ? Only approved materials are used. ? Samples are taken, as appropriate, during and/or after processing, transfer or filling for testing for adequacy of mixing or other forms of processing, absence of hazardous microanisms or chemical contaminants, and pliance with any other acceptance specification. ? Weighing and measuring of raw materials is checked by a second person, and containers holding the materials are properly identified. 54 Cosmetic / Drug GMP’s ? Production (continued) ? Major equipment, transfer lines, containers and tanks are used for processing, filling or holding cosmetics are identified to indicate contents, batch designation, control status and other pertinent information. ? Labels are examined for iden