【文章內(nèi)容簡(jiǎn)介】 ................................................................. 59 . 第六節(jié) 糾正措施和預(yù)防措施 ...................................................................................... 60 . Section 6 Corrective action and preventive action (CAPA) .................................... 60 . 第七節(jié) 供應(yīng)商的評(píng)估和批準(zhǔn) ...................................................................................... 61 . Section 7 Audit and approal of suppliers .................................................................. 61 . 第八節(jié) 產(chǎn)品質(zhì)量回顧分析 .......................................................................................... 63 . Section 8 Product Quality Review ............................................................................. 63 . 第九節(jié) 投訴與不良反應(yīng)報(bào)告 .................................................................................... 65 . Section 9 Complaints and Adverse Reactions Report ............................................ 65 第十一章 委托生產(chǎn)與委托檢驗(yàn) ...................................................................................... 66 Chapter 11 Contract manufacture and analysis ............................................................ 66 . 第一節(jié) 原 則 .............................................................................................................. 66 . Section 1 Principle ...................................................................................................... 66 . 第二節(jié) 委托方 .............................................................................................................. 66 . Section 2 The Contract Giver .................................................................................... 66 . 第三節(jié) 受托方 .............................................................................................................. 66 . Section 3 The Contract Acceptor .............................................................................. 66 . 第四節(jié) 合 同 .............................................................................................................. 67 . Section 4 The Contract .............................................................................................. 67 第十二章 產(chǎn)品發(fā)運(yùn)與召回 ............................................................................................. 68 Chapter 12 Product distribution and recall ..................................................................... 68 . 第一節(jié) 原 則 .............................................................................................................. 68 . Section 1 Principle ...................................................................................................... 68 . 第二節(jié) 發(fā) 運(yùn) .............................................................................................................. 68 . Section 2 Distribution ................................................................................................. 68 . 第三節(jié) 召 回 .............................................................................................................. 68 . Section 3 Recalls ........................................................................................................ 68 第十三章 自 檢 ............................................................................................................. 69 Chapter 13 Self inspection ............................................................................................ 69 . 第一節(jié) 原 則 ........................................................................................................... 69 . Section 1 Principle ............................................................................................... 69 . 第二節(jié) 自 檢 ........................................................................................................... 69 . Section 2 Self inspection ......................................................................................... 69 第十四章 附 則 ............................................................................................................. 70 Chapter 14 Glossary .................................................................................................... 70 Note: Highlight (Yellow) is the differences between EU GMP and SFDA GMP (new version). The first difference is that Chinese GMP bines all the requirements for both API and medicinal products, while EU GMP divides them to two parts. No highlight: is the similarity between the two guidelines. 第一章 總 則 Chapter1 General Provisions 第 一條 為規(guī)范藥品生產(chǎn)質(zhì)量管理，根據(jù)《中華人民共和國(guó)藥品管理法》、《中華人民共和國(guó)藥品管理法實(shí)施條例》，制定本規(guī)范。 Article 1. This regulation is enacted to regulate the standards of Pharmaceutical Manufacturing and Quality Management in accordance with the Drug Administration Law of the People s Republic of China and Regulations for Implementation of Drug Administration Law of the People s Republic of China . 第二條 企業(yè)應(yīng)當(dāng)建立藥品質(zhì)量管理體系。該體系應(yīng)當(dāng)涵蓋影響藥品質(zhì)量的所有因素，包括確保藥品質(zhì)量符合預(yù)定用途的有組織、有計(jì)劃的全部活動(dòng)。 Article 2. A pharmaceutical enterprise should establish Quality Management system which shall cover all factors impacting products quality, includes anized and planned all activities to ensure products quality fit for intended use. 第三條 本規(guī)范作為質(zhì)量管理體系的一部分，是藥品生產(chǎn)管理和質(zhì)量控制的基本要求，旨在最大限度地降低藥品生產(chǎn)過(guò)程中污染、交叉污染以及混淆、差錯(cuò)等風(fēng)險(xiǎn)，確保持續(xù)穩(wěn)定地生產(chǎn)出符合預(yù)定用途和注冊(cè)要求的藥品。 Article 3. As part of Quality Management system, this regulation is the basic requirement for manufacturing management and quality control. The purpose is to afford maximizing reduction in the risks of contamination, cross contamination, mixup and error, to ensure that products are consistently produced with intended use and registrations. 第四條 企業(yè)應(yīng)當(dāng)嚴(yán)格執(zhí)行本規(guī)范，堅(jiān)持誠(chéng)實(shí)守信，禁止任何虛假、欺騙行為。 Article 4. Enterprises shall execute this regulation strictly, with honesty and trustworthiness, prohibiting any false and cheating activities. 第二章 質(zhì)量管理 Chapter 2 Quality management 第一節(jié) 原 則 Section 1 Principle 第五條 企業(yè)應(yīng)當(dāng)建立符合藥品質(zhì)量管理要求的質(zhì)量目標(biāo)，將藥品注冊(cè)的有關(guān)安全、有效和質(zhì)量可控的所有要求