【正文】 的要求 ? ISO13485指所有針對(duì)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(zé)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。 現(xiàn)行是指用以控制生產(chǎn)，進(jìn)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。 Examples of Class I devices: Unscented Pads or Liners Examination gloves Adult incontinence – exempt 一級(jí)別產(chǎn)品引例： 無(wú)氣味的襯墊 測(cè)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(jí)品除了先期市場(chǎng)告知外，都必須遵守良好的生產(chǎn)實(shí)踐定律。 What is a Complaint?什么是投訴 32 ? Requirements are discussed in 21CFR 要求在 21CFR ? The regulation requires 規(guī)章要求 ? Documented procedures 進(jìn)程文檔記錄 ? Timely and uniform processing 及時(shí)一致的處理 ? Process for evaluation/investigation 評(píng)估方法 ? Adverse event consideration (serious injury or death)不利方面的考慮（嚴(yán)重的損傷或死亡） ? Additional requirements apply to plaints alleging serious injury or death (21 CFR 803) 正對(duì)嚴(yán)重?fù)p傷或死亡的申訴的額外要求（ 21CFR803) What About Complaint Files? 投訴文件 33 ? A pilation of records containing the production history of a finished device. 記錄需包含每個(gè)成品的生產(chǎn)歷史 ? A DHR includes DHR包含 ? Dates of manufacture 生產(chǎn)日期 ? Quantity manufactured and released 數(shù)量和生產(chǎn) ? Acceptance records 可接受記錄 ? Primary identification label 主要確認(rèn)標(biāo)記 ? Device identification and lot number 產(chǎn)品確認(rèn)和生產(chǎn)標(biāo)號(hào) What is a DHR?DHR是什么？ 34 ? Maintained at the manufacturing site or otherwise reasonable ? Legible and plete (errors must be appropriately corrected) 易讀的和完成的（錯(cuò)誤必須適當(dāng)糾正） ? Retained for the life of the product (minimum 2 years from date of release).產(chǎn)品壽命需維持從生產(chǎn)日期起至少 2年） ? Exceptions include Management Review, Quality Audits and Supplier ，質(zhì)量審核和供應(yīng)商審核 Record Requirements 記錄要求 35 ? Additional requirements ? Electronically stored – must be backed up ? Electronically created – must ply with Part 11 requirements ? Electronically signed – must ply with Part 11 requirements ? CSV Roadmap VFlow/CSV% ? 額外要求 ? 電子儲(chǔ)藏 必須后備 ? 電子生成 必須與 11章節(jié)要求一致 ? 電子簽署 必須與 11章節(jié)要求一致 ? CSV路徑VFlow/CSV% Electronic Record Requirements 電子記錄要求 36 Design Verification and Validation, Process Validation 設(shè)計(jì)及方法確認(rèn)和批準(zhǔn) ? Design Verification and Validations ? Must verify design “Output” meets “Input”. ? Must validate design under normal operating conditions with production product. ? Design validation must Risk assessments. ? 設(shè)計(jì)的確認(rèn)和批準(zhǔn) ? 必須確認(rèn)設(shè)計(jì)從生產(chǎn)和出產(chǎn)的一致 ? 必須在常規(guī)產(chǎn)品生產(chǎn)操作的情況下批準(zhǔn)設(shè)計(jì) ? 設(shè)計(jì)批準(zhǔn)必須經(jīng)過(guò)風(fēng)險(xiǎn)評(píng)估 ? Process Validations 方法批準(zhǔn) ? Where results of a process can not be verified, a process shall be validated, ., bioburden, cleaning, sanitization, etc. 當(dāng) 一種方法的結(jié)果不被查證時(shí)， 37 Change Requirements 改動(dòng)要求 Change control process for the identification, documentation, validation, or where appropriate verification, review and approval of changes before implementation. 改變控制進(jìn)程是在改變實(shí)施之前，針對(duì)改變的，審閱，查證，認(rèn)可隨后做出相應(yīng)的審批，法律批文和文檔的過(guò)程。s primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.“ 66 Medical Device cGMPs Subpart A – General Provisions 167。 Quality Audit 70 Medical Device cGMPs Subpart B – Quality System Requirements 167。 maintain records of acceptable suppliers 73 Medical Device cGMPs Subpart E – Purchasing Controls 167。 Purchasing Controls Procedures for ensuring received product amp。 Authority Resources Management Representative 68 Medical Device cGMPs Subpart B – Quality System Requirements Management Review Management with Executive responsibility reviews the suitability and effectiveness of the quality system at defined intervals. Quality Planning Quality Plan Quality Practices Resources Activities Established how the plan will be met Quality System Procedures Procedures Outline of Structure 167。 ? 裝置物，電線以及管道等必須被合理安裝，以避免有房屋滲漏現(xiàn)象導(dǎo)致機(jī)械表面，籮筐里面的成品的破損。 Example of Class III device: 級(jí)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。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。 5 GMP History GMP歷史 Food and Drug Administration Federal Food, Drug and Cosmetic Act of 1938, as Amended: 1938年美國(guó)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(jí)或被錯(cuò)誤標(biāo)記的食品，藥品，設(shè)備和化妝品國(guó)際貿(mào)易中的變動(dòng)，以確保消費(fèi)者的利益不被危險(xiǎn)性的或者帶有欺騙性的標(biāo)簽和包裝的產(chǎn)品所侵害。 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(jí) 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(jí)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(jí)別的產(chǎn)品還受控于特殊控制。 These changes include, but are not limited to: 這些改變包含以下方面但不僅限于此： ? Design 設(shè)計(jì) ? Process 進(jìn)程 ? Software 軟件 ? Cleaning 清潔 ? Sanitization 清除干凈 38 GMP Controls What needs to be in place? 什么適當(dāng)?shù)姆矫嫘枰?GMP控制 ? Understand the scope, risk and regulations ? Assess risks – HACCP ? Product History ? 領(lǐng)會(huì)范圍，風(fēng)險(xiǎn)及規(guī)章 ? 評(píng)估風(fēng)險(xiǎn) HACCP 危害分析關(guān)鍵控制點(diǎn) ? 產(chǎn)品歷史 39 Risk Assessment Scope 風(fēng)險(xiǎn)評(píng)估范圍 40 How do we assess GMP risks? 我們?nèi)绾卧u(píng)估 GMP風(fēng)險(xiǎn)？ HACCP is a proactive systematic approach to the identification, assessment of risk and severity, and control of biological, chemical, and physical haz