【正文】 he attending physician. ? The name(s) and location(s) of any poison control center, government agency, physician39。 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 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，地址和產(chǎn)品名稱的注冊(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。C Act o 必須遵照美國(guó)聯(lián)邦政府食品，設(shè)備藥物管制規(guī)程 o 必須遵照美國(guó)公平包裝標(biāo)式法 o 必須遵照由上述權(quán)威法律所簽署的相關(guān)規(guī)章 o 必須實(shí)施美國(guó)聯(lián)邦政府食品藥物管制規(guī)程 14 When would we use GMP’s? 何時(shí)使用 GMP’s？ a. Production of regulated products b. Customer requirements c. Business requirements d. Protect the brand or business e. Protect our C/S/C/U. f. 符合規(guī)則的產(chǎn)品生產(chǎn) g. 客戶要求 h. 商業(yè)要求 i. 保護(hù)品牌和商業(yè) j. 保護(hù)我們的 C/S/C/U 15 ? Also known as 21 CFR 820, Part 820, cGMP ? Applies to all medical device firms ? Most Class 1 devices are exempt from design controls ? Some very low risk Class 1 devices are exempt from all except plaint handling and record keeping requirements ? 作為最新食物藥品生產(chǎn)質(zhì)量規(guī)范章程，章節(jié) 820 ? 適用所有醫(yī)療產(chǎn)品商 ? 絕大多數(shù)級(jí)別一的產(chǎn)品免除設(shè)計(jì)方面的控制 ? 一些風(fēng)險(xiǎn)較小的級(jí)別一的產(chǎn)品可免除除了處理投訴和保持記錄以外的其他要求 FDA Quality System Regulation 美國(guó)聯(lián)邦政府質(zhì)量體系規(guī)章 16 Medical Device cGMPs 醫(yī)療設(shè)備動(dòng)態(tài)藥品生產(chǎn)管理規(guī)范 Medical Device Classes:醫(yī)療設(shè)備等級(jí) Class I 等級(jí) Ⅰ Class I devices are subject 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。1 Objectives 培訓(xùn)目的 o Introduction to GMP?s? o 良好生產(chǎn)操作規(guī)范（ GMP?s) 概述 o Why do we need GMP?s o 我們?yōu)槭裁葱枰?GMP?s？ o When to we use GMP?s? o 我們何時(shí)需要用到 GMP?s？ o General Overview of basic cGMP Requirements o CGMP基本要求總攬 o Key differences from the QMS o 與質(zhì)量管理體系的關(guān)鍵區(qū)別 o Implementing for success o 成功的方法 2 Introduction to GMP’s 良好生產(chǎn)操作規(guī)范引言 a. GMP?s defined b. History c. Applications d. GMP?s 定義 e. 歷史 f. 適用范圍 3 cGMP’s Overview最新食品及藥物生產(chǎn)質(zhì)量管理規(guī)范 概要 North Asia Quality Managers Meeting March 6, 2020 Taipei Taiwan 北亞質(zhì)量經(jīng)理會(huì)議 2020， 3， 6，臺(tái)北，臺(tái)灣 4 Current Good Manufacturing Practices (cGMP) 最新食品及藥物生產(chǎn)質(zhì)量管理規(guī)范 Good Manufacturing Practices are…. the current minimum guidelines for controlling the manufacturing, processing, packing and holding of drug products to assure that the products are safe for use, are properly identified, of proper strength, and of appropriate quantity and quality. 生產(chǎn)管理規(guī)范是指。一級(jí)別的產(chǎn)品在常規(guī)控制中和級(jí)別二三相同。 Validation ? Device Master Record (DMR) ? Device History Record (DHR) ? Quality System Regulation ? Electronic Records ? Process Validation ? Change Controls ? Registrations and Approvals ? Others ? 投訴方法 ? 設(shè)計(jì)認(rèn)可和確認(rèn) ? 產(chǎn)品主要記錄 ? 產(chǎn)品歷史記錄 ? 質(zhì)量體系規(guī)章 ? 電子記錄 ? 方法確認(rèn) ? 改變控制 ? 登記和認(rèn)可 ? 其他 31 ? Any written, electronic or oral munication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. 任何落筆的，電子的或口頭交流的關(guān)于在產(chǎn)品出產(chǎn)或分銷后，對(duì)產(chǎn)品的說(shuō)明，質(zhì)量，耐久性，可靠和安全性的不完備的申訴。s group etc., to whom formula information and/or toxicity data are provided. ? Whether the firm voluntarily files Cosmetic Product Experience Reports (21 CFR 730). 61 Cosmetic / Drug GMP’s ? Other ? Participating in the program of voluntary registration of: ? Cosmetic manufacturing est