【正文】 smetic manufacturing establishments (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。 ? 地板，墻壁和天花板必須平整的建筑，并較易的可做表面清潔和良好的維修。 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，對產(chǎn)品的說明，質(zhì)量，耐久性，可靠和安全性的不完備的申訴。 Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 級別三的產(chǎn)品通常是那些用以支持和維護(hù)人類生活，并避免發(fā)生人體傷害或潛在及不合理的傷害風(fēng)險的具有實質(zhì)重要性的產(chǎn)品。一級別的產(chǎn)品在常規(guī)控制中和級別二三相同。 7 Food and Drug Administration 食品和藥物管制 Basic FDA Product Requirements ? Safe for intended use ? Drugs and devices effective for intended use ? Not adulterated (., contains what, and only what, it is supposed to contain) ? Not misbranded (., labeled as it should be) ? Manufactured in pliance with applicable cGMPs ? 美國聯(lián)邦政府食品藥物管制基本要求 ? 產(chǎn)品用途安全性 ? 藥品及設(shè)備有效使用 ? 未滲入次品（如產(chǎn)品包含成分，僅有成分等） ? 無錯誤標(biāo)記（如標(biāo)簽） ? 按照可行的最新食品及藥品生產(chǎn)質(zhì)量規(guī)范進(jìn)行生產(chǎn) 8 Why do we need GMP’s 我們?yōu)楹涡枰幤飞a(chǎn)管理規(guī)范？ a. Where is KC going? b. Liability c. Compliance (FDA audits and reports) d. KC在哪些方面實施？ e. 職責(zé) f. 承諾 (美國聯(lián)邦政府食品藥物管理局審核和報告） 9 KC Direction KC引言 ? “ A host of internal and external challenges are driving significant change within KimberlyClark. Therefore, we are making changes to bee a winning global health and hygiene pany.” (taken from the KC Intra GBP site) ? 一系列內(nèi)外部的挑戰(zhàn)正隨著金伯利發(fā)生著強大的變化。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。 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(jī)構(gòu)。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(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(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