【正文】 entification, assessment of risk and severity, and control of biological, chemical, and physical hazards/contamination associated with a product, production process or practice. HACCP是一種較有體系的方法，使產(chǎn)品在生產(chǎn)實踐過程中，對產(chǎn)品生物化學(xué)物理技能等方面的風險及嚴肅性的審查及評估。 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)計認可和確認 ? 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 ? 改變控制 ? 登記和認可 ? 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。 Listing (21CFR 807) ? Quality System Regulation (21 CFR 820) with exemptions ? 醫(yī)療產(chǎn)品報告 ? 更正，解除 ? 標注 ? 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？ 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標記必須按照附錄 XII中描述的進程貼上 What Other Quality System Standards Apply?其他質(zhì)量體系標準適用什么？ 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，并對身體不造成任何的傷害。 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險的具有實質(zhì)重要性的產(chǎn)品。 17 Medical Device cGMPs 醫(yī)療產(chǎn)品的最新生產(chǎn)質(zhì)量操作規(guī)范 Class II 等級 II Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. In addition to plying with general controls, Class II devices are also subject to special controls. 二級別的產(chǎn)品是指那些在一般控制下還未足夠保證安全性能及效果的情況下，并存有其他技術(shù)以更好的確保其安全性，除一般控制之外，二級別的產(chǎn)品還受控于特殊控制。一級別的產(chǎn)品在常規(guī)控制中和級別二三相同。（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)誠信和展望 ? 產(chǎn)品安全性 ? 滿足客戶要求 ? 僅被認可的材料 ? 合理有效的包裝 ? 精確的商標及標識 ? 企業(yè)生產(chǎn)標準 ? 安全監(jiān)查預(yù)備 11 Why cGMPs？為何實施 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 o 保護我們消費者的利益 o 保護我們的商業(yè)機會 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?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)要求指所有針對特有的質(zhì)量體系而調(diào)整的要求 ? ISO13485指所有針對特有的質(zhì)量體系而調(diào)整的要求 ? ISO 9001不包含所有的 GMP要求 13 Legal Responsibilities 法律責任 o Must ply with the Federal Food, Device, Drug, and Cosmetic Act o Must ply with the Fair Packaging and Labeling Act o Must ply with Regulations issued under the authority of these Laws o Enforced as part of the FDamp。 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） ? 無錯誤標記（如標簽） ? 按照可行的最新食品及藥品生產(chǎn)質(zhì)量規(guī)范進行生產(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 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。 5 GMP History GMP歷史 Food and Drug Administration Federal Food, Drug and Cosmetic Act of 1938, as Amended: 1938年美國聯(lián)邦政府食品藥物管理規(guī)范規(guī)定： To protect the consumers from unsafe or deceptively labeled or packaged products by prohibiting the movement in interstate merce of adulterated or misbranded food, drug, devices and 次級或被錯誤標記的食品，藥品，設(shè)備和化妝品國際貿(mào)易中的變動，以確保消費者的利益不被危險性的或者帶有欺騙性的標簽和包裝的產(chǎn)品所侵害。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. Applic