PIC GMP简介翻译.docx

PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME国际医药品稽查协约组织(PIC/S)2015年10月GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS良好生产规范药用产品的指南INTRODUCTION 简介General综述In order to further facilitate the removal of barriers to trade in medicinal products, to promote uniformity in licensing decisions and to ensure the maintaining of high standards of quality assurance in the development, manufacture and control of medicinal products, the following Guide to Good Manufacturing Practice for Medicinal Products and its Annexes has been adopted.为了进一步促进医药产品的贸易壁垒的去除，促进许可决定的一致性，确保质量保证在开发、制造和医药产品的控制方面高标准的维护，采用良好生产规范医药产品的以下指南及其附件。The standards set out herein apply to medicines and similar products intended for human use. It is recommended, however, that the same kind of attention be given to the manufacture of veterinary products. Administrative measures of national health authorities should be directed towards the application of these standards in practice, and any new or amended national regulations for good manufacturing practice should at least meet their level. These standards are also intended to serve manufacturers as a basis for the elaboration of specific rules adapted to their individual needs.本标准的制定适用于供人类使用的药品和类似产品。不过建议同样适用于兽药产品的生产。国家卫生当局的行政措施应针对这些标准在实践中的应用，新的或修订GMP国家规范至少应该满足他们的要求。这些标准也旨在为生产商作为特定规则的细化的基础适应他们的个人需求。这些标准也旨在为生产商提供细化的特定规则为基础以适应他们的个人需求It is recognised that there are acceptable methods, other than those described in this Guide, which are capable of achieving the principles of the Guide. This Guide is not intended to place any restraint upon the development of new concepts or new technologies, which have been validated and provide a level of Quality Assurance at least equivalent to those set out in this Guide. 除了本指南中描述的，还有其他可以接受的方法能够实现指南中的原则。本指南并不想对新概念或新技术的发展进行任何限制，这些新概念或新技术已验证并提供至少相当于在本指南所述的质量保证水平。The Guide is divided into two parts and a number of annexes which are common to both parts. Part I covers GMP principles for the manufacture of medicinal products. Part II covers GMP for active substances used as starting materials. The annexes provide detail on specific areas of activity. For some manufacturing processes, different annexes will apply simultaneously (e.g. annex on sterile preparations and on radiopharmaceuticals and/or on biological medicinal products). A glossary of some terms used in the Guide has been incorporated after the annexes. A specific glossary for APIs can be found at the end of Part II. 该指南分为两部分和附件这常见的两个部分。第一部分介绍医药产品生产的GMP原则。第二部分介绍作为起始物料的活性物质的GMP。附件提供活动的具体领域详情。同时对于一些生产流程，将使用不同的附件(如附件无菌制剂和放射性药物和/或生物医药产品)。指南中使用的术语的术语表编入附件后。APIs的特定术语表在第二部分结尾可以找到。History 历史Part I of the PIC/S GMP Guide PIC/S GMP指南的第一部分Originally, the PIC/S GMP Guide (“PIC Basic Standards” of 1972) derives from the WHO GMP Guide and was further developed in order to comply with stringent manufacturing and health requirements in PIC/S countries, to cover new areas (e.g. biologicals, radiopharmaceuticals, etc.) and to adapt to scientific and industrial technology (e.g. biotech, parametric release etc.). The aim of such improvements was to ensure that high quality medicines were produced in line with the PIC Convention and then the PIC Scheme.最初，PIC/S GMP指南(1972 PIC基本标准)源于WHO GMP指南，并为遵守严格的生产和PIC / S国家的卫生需求，覆盖新领域(如生物制剂、放射性药物等)和适应科学工业技术(如生物技术、参数版本等)进行进一步的发展。这种改进的目的是确保高质量的药品生产符合PIC公约和PIC方案。In 1989, the EU adopted its own GMP Guide, which in terms of GMP requirements was equivalent to the PIC/S GMP Guide. Since that time, the EU and the PIC/S GMP Guides have been developed in parallel and whenever a change has been made to one, the other has been amended so that both Guides are practically identical.在1989年，欧盟采用自己的GMP指南-依据 GMP的要求-相当于PIC/S GMP指南。从此，欧盟和PIC/S GMP指南并行发展，只要一方做出变更，另一方会进行修订，因此这两个指南几乎是相同的。There are, however, some differences between the two Guides. These differences are the following:然而，这两个指南也有一些差异。这些差异如下： the definition of Pharmaceutical Product (referred to as “Medicinal Product” in this Guide), which is found in Article 1 of the Pharmaceutical Inspection Convention, has been retained;医药产品的定义(在本指南称为“药品”)出现在药品检验公约的第一条，一直保留 references to the EU Directives, as well as to MRAs, have been deleted;引用欧盟指令,以及MRAs已经被删除了 the expression “authorised person” (see Glossary) is used in the PIC/S Guide while the expression “Qualified Person” is used in the EU Guide; “授权人”的表达(见术语表)在PIC/S指南中使用，而在欧盟指南中使用“有资质的人”; since not all Participating Authorities under the PIC Scheme are parties to the European Pharmacopoeia Convention, the mention of “European Pharmacopoeia” in the Guide has been amended to read “European or other relevant Pharmacopoeia”.因为按照PIC方案并不是所有参与部门是欧洲药典公约缔约方,指南中提到的“欧洲药典”已修改为“欧洲或其他相关药典”Part II of the PIC/S GMP Guide PIC/S GMP指南的第二部分On 22 May 2001, the PIC/S Committee adopted the “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A) developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a stand-alone guide (PE 007). It is recalled that the first draft of this GMP Guide for APIs was elaborated by PIC/S, before it was transferred to ICH. At its Dsseldorf meeting on 29-30 May 2006, the PIC/S Committee decided to make it Part II of the current Guide.2001年5月22日，PIC/S委员会采用了“活性药物成分的良好生产规范指南”(ICH Q7A)，人用药物注册技术要求国际协调会议（ICH）发展起来的作为一个独立的指导(PE 007)。在传给ICH之前，PIC/S阐述了APIs GMP指南的初稿。在2006年5月29 - 30日的杜塞尔多夫会议上，PIC/S委员会决定完成当前指南的第二部分。ADOPTION AND ENTRY INTO FORCE采用及生效Adoption by the Committee of PE 009-12PE 009-12委员会采用23 March 20152015年3月23Entry into force of PE 009-12PE 009-12生效1 October 20152015.10.01REVISION HISTORY修订历史Date VersionNumberReasons for revision21 December 20002000.10.21PH 1/97 (Rev.) Revision of Annex 14附件14修订 Renumbering of all annexes附件的重新编号 Change in the editors address and insertion of copyright statement编辑地址和插入的版权声明的更改 Inclusion of revision history修订历史10 August 2001 2001.08.10PH 1/97 (Rev. 2) Amendment of para. 42 of Annex 1附件1的修订 Revision of Annex 6附件6的修订 New Annex 15新的附件15 New Annex 17新的附件17 Amendment to the glossary术语表的修订15 January 20022002.01.15PH 1/97 (Rev. 3) New Annex 4 新附件4 New Annex 5新附件5 Reference to Annex 18 of EC GMP GuideEC GMP指南附件18的参考1 September 20032003.09.01PE 009-1 Amendment of Annex 1 (mainly section 3)附件1的修订（主要第三部分）1 July 20042004.06.01PE 009-2 Revision of Annex 13附件13的修订 Change in the Editors co-ordinates编辑坐标的更改1 January 20062006.01.01PE 009-3 Revision of Chapter 1第1章的修订1 June 2006 2006.06.01PE 009-4 Revision of Chapter 6第6章的修订1 August 2006 PE 009-5 Corrections to revision of Chapter 6第6章修订本的修订 Revision of Chapter 8第8章的修订5 April 2007PE 009-6 Reorganisation of the PIC/S GMP Guide in Part I, Part II and AnnexesPIC/S GMP指南在第1、2部分和附件的重组 Incorporation of PE 007 (APIs guide) as Part II PE 00