PIC/S介绍
The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970.
The PIC/S’ mission is to lead the international development, implementation and maintenance of harmonised Good Manufacturing Practice (GMP) standards and quality systems of inspectorates in the field of medicinal products.
PIC/S 成立于1995年，是1970年《PIC》的延伸。
PIC/S的使命是领导药品领域的良好生产规范（GMP）标准和检查员质量体系的国际开发、实施和维护。
PIC/S GMP Guide 介绍：
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.
为了进一步促进消除医药产品贸易壁垒，促进许可证决定的一致性，并确保在医药产品的开发、制造和控制方面保持高标准的质量保证，通过了以下《药品良好生产规范指南》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.
这些标准适用于人用药品和类似产品。然而，建议对兽用产品的生产给予同样的关注。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，任何新的或修订的国家法规至少应达到其水平。这些标准还旨在为制造商提供依据，以制定适合其产品需求的具体规则。
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.
人们认识到，除本指南所述方法外，还有一些可接受的方法能够实现本指南的原则。本指南无意对新概念或新技术的开发施加任何限制。这些新概念或技术已经过验证，并提供了至少与本指南中规定的质量保证相当的水平。
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.
《指南》分为两部分和若干附件，这两部分都有共同之处。第一部分介绍了药品生产的GMP原则。第二部分涵盖了用作原料的活性物质的GMP。附件详细说明了具体的活动领域。对于某些生产过程，不同的附件将同时适用（例如关于无菌制剂和放射性药物和/或生物医药产品的附件）。《指南》中使用的一些术语的词汇表已纳入附件。API的特定词汇表可以在第二部分的末尾找到。
_00_1685605703063.jpg)
