【正文】 ablishments (21 CFR 710). ? Cosmetic product ingredient and cosmetic raw material position statements (21 CFR 720). ? Cosmetic product experiences (21 CFR 730). ? Using a color additive which is not listed for use in cosmetics (21 CFR 73, 74, and 82) or which is not certified (21 CFR 80). ? Using a prohibited cosmetic ingredient (21 CFR 700). 62 Cosmetic / Drug GMP’s An appropriate quality system to meet the applicable regulations 63 Appendix B ? Medical Device GMP?s 64 Medical Device cGMPs General controls include: Establishment Registration (use FDA Form 2891) of panies which are required to register under 21 CFR Part , such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA. Medical Device Listing (use FDA Form 2892) with FDA of devices to be marketed. Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820. Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809. Submission of a premarket notification [510(k)] before marketing a device. 65 Medical Device cGMPs A medical device is: ? an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a ponent part, or accessory which is: ? recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, ? intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or ? intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it39。 dates are documented 167。 select on basis of meeting requirements, document evaluation ? Define control based on evaluation results ? Establish amp。 services conform to specified requirements. Evaluations (suppliers, contractors, amp。 Management Responsibility (continued) 69 Medical Device cGMPs Subpart B – Quality System Requirements Quality audit procedures shall be in place to assure: Quality system is in pliance Determination of effectiveness of system Quality audits Auditor shall be independent Corrective Actions taken Audit reports Audits amp。 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(gè)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(gè)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 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(zhuǎn)用途的設(shè)備和器具必須有適當(dāng)?shù)脑O(shè)計(jì)，原料和工藝。 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(guó)聯(lián)邦政府食品藥物管理規(guī)定適用什么？ 20 ? 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？ 21 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(duì)身體不造成任何的傷害。（摘自 KC企業(yè)內(nèi)部 GBP網(wǎng)） 10 KC Expectations KC的期望 ? Corporate Integrity and Expectations ? Product Safety Clearances ? Meets Customer Requirements ? Only Approved Materials ? Properly and Effectively Packaged ? Accurately Branded and Labeled ? Corporate Manufacturing Standards ? Ensure inspection readiness ? 企業(yè)誠(chéng)信和展望 ? 產(chǎn)品安全性 ? 滿足客戶要求 ? 僅被認(rèn)可的材料 ? 合理有效的包裝 ? 精確的商標(biāo)及標(biāo)識(shí) ? 企業(yè)生產(chǎn)標(biāo)準(zhǔn) ? 安全監(jiān)查預(yù)備 11 Why cGMPs？為何實(shí)施 cGMP?s? o It?s good business o Protect our consumers o Protect our business o Customer requirements o Maintain regulatory pliance o Rules for producing Safe and Clean Products o Part of an appropriate Quality System o 良好的商機(jī) o 保護(hù)我們消費(fèi)者的利益 o 保護(hù)我們的商業(yè)機(jī)會(huì) o 客戶要求 o 遵守規(guī)范的承諾 o 產(chǎn)品安全性和整潔度的規(guī)范 o 適當(dāng)?shù)馁|(zhì)量體系 12 GMP’s are part of an “Appropriate” Quality System GMP’s是特有的質(zhì)量體系 ? The KimberlyClark Quality Management System requirements (QMS) includes all regulatory requirements for a “appropriate” quality system. ? ISO 13485 includes all regulatory requirements for a “appropriate” quality system. ? ISO 9001 does not include all GMP requirements ? 金伯利質(zhì)量管理體協(xié)要求指所有針對(duì)特有的質(zhì)量體系而調(diào)整