【正文】 ations 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)理會議 2020， 3， 6，臺北，臺灣 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。 現(xiàn)行是指用以控制生產(chǎn)，進程，包裝和保持藥品的最小方針，以此確保產(chǎn)品固有的數(shù)量及質(zhì)量，并安全的被使用。 6 Food and Drug Administration 食品，藥品規(guī)程 The . Food and Drug Administration (FDA) is a public health agency that is charged with protecting American consumers by enforcing the . Federal Food, Drug, and Cosmetic Act and other related public health laws. 美國食品藥物管理局是通過實施美國聯(lián)邦政府食品藥物管制及其他相關(guān)公眾健康法規(guī)，以確保美國消費者健康的公眾機構(gòu)。因此，我們正在朝著全球領(lǐng)先的健康衛(wèi)生產(chǎn)品公司而努力著。C Act o 必須遵照美國聯(lián)邦政府食品，設(shè)備藥物管制規(guī)程 o 必須遵照美國公平包裝標式法 o 必須遵照由上述權(quán)威法律所簽署的相關(guān)規(guī)章 o 必須實施美國聯(lián)邦政府食品藥物管制規(guī)程 14 When would we use GMP’s? 何時使用 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. 保護品牌和商業(yè) j. 保護我們的 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)級別一的產(chǎn)品免除設(shè)計方面的控制 ? 一些風(fēng)險較小的級別一的產(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 美國聯(lián)邦政府質(zhì)量體系規(guī)章 16 Medical Device cGMPs 醫(yī)療設(shè)備動態(tài)藥品生產(chǎn)管理規(guī)范 Medical Device Classes:醫(yī)療設(shè)備等級 Class I 等級 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. 一級別的產(chǎn)品受調(diào)整的控制，并相對于級別二和三而言，在設(shè)計上較為簡單但對使用者幾乎沒有任何的傷害。 Examples of Class I devices: Unscented Pads or Liners Examination gloves Adult incontinence – exempt 一級別產(chǎn)品引例： 無氣味的襯墊 測試手套 Note:Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation. 注意：大多數(shù)一級品除了先期市場告知外，都必須遵守良好的生產(chǎn)實踐定律。 Examples of Class II devices:二級別產(chǎn)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(chǎn)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(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產(chǎn)品的安全性的產(chǎn)品。 Example of Class III device: 級別三的產(chǎn)品舉例： implantable pacemaker 植入式心臟起博器 19 ? Medical Device Reporting (21CFR 803) ? Corrections, Removals and Withdrawals (21CFR 806) ? Labeling (21CFR 801) ? Electronic Records, Electronic Signatures (21CFR 11) ? Registration amp。 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 僅是個方針 ? 生產(chǎn)者必須對產(chǎn)品的安全性負責(zé)（如不可有次品） ? 無任何有毒物質(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，儲存，分銷 FDA Facility Registration Cosmetic Products 美國聯(lián)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(chǎn)及包裝設(shè)備的注冊 ? 公司名稱，地址和產(chǎn)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(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 錯誤標記產(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(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(chǎn)品及進程控制 ? H. Acceptance Activities 可接受性 ? I. Nonconforming Product 非確認產(chǎn)品 ? J. Corrective and Preventive Action 糾正及預(yù)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(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準 ? 質(zhì)量管理體系高級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。 What is a Complaint?什么是投訴 32 ? Requirements are di