PIC/S PE 009-18《药品生产质量管理规范指南》引言卷中英双语全文

本文译述自 PIC/S PE 009-18《Guide to Good Manufacturing Practice for Medicinal Products》（© PIC/S 2026，英文原版非商业用途引用）。中文为学习性译文，原文与译文冲突时以英文原版为准。PIC/S Secretariat · www.picscheme.org

PE 009-18 引言卷·中英双语全文

这一篇决定了后面 Part I / Part II / 附录卷 的读法

PE 009-18 是 PIC/S 的 GMP 总纲：它讲清了这份指南从哪来、分哪几部分、和欧盟 GMP 差在哪、版本号怎么演进。

一句话——读懂引言，再看后面九篇，才不会断章取义。

引言

INTRODUCTION

总则 为进一步消除药品贸易壁垒、促进许可审批决策的统一，并确保药品研发、生产与质量控制中质量保证的高标准得以持续维持，特通过本《药品生产质量管理规范指南》（PE 009-18）及其附录。 本规范所载标准适用于拟供人用药品及类似产品。但建议对兽用产品的生产给予同等关注。各国药品监管机构的行政措施应着眼于将这些标准付诸实践，任何新制定或修订的国家药品生产质量管理规范法规，其要求水平均不应低于本标准。这些标准亦旨在为生产企业制定适合自身具体需要的专项规则提供依据。 公认存在本规范所述方法之外、亦能实现本规范原则的其他可接受方法。本规范无意限制新概念或新技术的发展，只要此类概念或技术经过验证，并能提供至少与本规范相当的质量保证水平。

General 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. 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. 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.

本指南分为两部分及若干对两部分均适用的附录。第一部分涵盖药品生产的GMP原则；第二部分涵盖用作起始物料的原料药的GMP要求。附录对特定活动领域提供详细规定。对于某些生产工艺，可能需同时适用多个附录（如无菌制剂附录与放射性药品附录和/或生物制品附录）。 本指南所用部分术语的词汇表附于附录之后。原料药专用词汇表见第二部分末尾。 历史 PIC/S GMP指南第一部分 PIC/S GMP指南最初（1972年“PIC基本标准”）源自WHO GMP指南，其后为满足PIC/S各国严格的生产与健康要求、覆盖新的领域（如生物制品、放射性药品等）并适应科学与工业技术的发展（如生物技术、参数放行等）而不断完善。此类改进旨在确保按照《药品检查公约》（PIC Convention）及随后的《药品检查合作计划》（PIC Scheme）生产高质量药品。 1989年，欧盟通过了其自身的GMP指南，就该指南的GMP要求而言，与PIC/S GMP指南等效。自那时起，欧盟与PIC/S两套GMP指南即并行发展，任一方作出修订，另一方亦相应修订，使两者实际上保持一致。

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. History Part I of the PIC/S GMP Guide 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. 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.

PE 009-18 经委员会通过 · 2026年9月22日

Adoption by the Committee of PE 009-18 · 22 September 2026

PE 009-18 生效 · 2026年9月24日

Entry into force of PE 009-18 · 24 September 2026

日期 · 版本号

Date · Version Number

修订原因

Reasons for revision

2000年12月21日 · PH 1/97（Rev.）

21 December 2000 · PH 1/97 (Rev.)

修订附录14

全部附录重新编号

更改编者地址并加入版权声明

增加修订历史

Revision of Annex 14

Renumbering of all annexes

Change in the editor’s address and

insertion of copyright statement

Inclusion of revision history

2001年8月10日 · PH 1/97（Rev. 2）

10 August 2001 · PH 1/97 (Rev. 2)

修订附录1第42段

修订附录6

新增附录15

新增附录17

修订词汇表

Amendment of para. 42 of Annex 1

Revision of Annex 6

New Annex 15

New Annex 17

Amendment to the glossary

但两套指南之间仍存在一些差异，具体如下： ➢ 保留了《药品检查公约》第1条中“药品”（Pharmaceutical Product，本指南中称为“Medicinal Product”）的定义；

There are, however, some differences between the two Guides. These differences are the following: ➢ 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;

➢ 删除了对欧盟指令及相互认可协议（MRA）的引用；

➢ references to the EU Directives, as well as to MRAs, have been deleted;

➢ PIC/S指南中使用“授权人”（authorised person，见词汇表）的表述，而欧盟指南中使用“质量受权人”（Qualified Person）的表述；

➢ the expression “authorised person” (see Glossary) is used in the PIC/S Guide while the expression “Qualified Person” is used in the EU Guide;

➢ 鉴于并非所有PIC合作计划的参与监管机构均为《欧洲药典公约》缔约方，本指南中“欧洲药典”的提法已修改为“欧洲药典或其他相关药典”。 PIC/S GMP指南第二部分 2001年5月22日，PIC/S委员会通过了由国际人用药品注册技术协调会（ICH）制定的《原料药生产质量管理规范指南》（ICH Q7A），作为独立指南发布（PE 007）。需要说明的是，该原料药GMP指南的初稿最初由PIC/S起草，后移交ICH。在2006年5月29日至30日于杜塞尔多夫召开的会议上，PIC/S委员会决定将其纳入为本指南的第二部分。 通过与生效

➢ 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”. Part II of the PIC/S GMP Guide 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 Düsseldorf meeting on 29-30 May 2006, the PIC/S Committee decided to make it Part II of the current Guide. ADOPTION AND ENTRY INTO FORCE

图示：Part I / Part II / 附录，是一套环

PE 009-18 生效 2026年9月24日 修订历史

Entry into force of PE 009-18 24 September 2026 REVISION HISTORY

图示：这份指南二十多年的修订轨迹

2002年1月15日 · PH 1/97（Rev. 3）

15 January 2002 · PH 1/97 (Rev. 3)

新增附录4

新增附录5

引用欧盟GMP指南附录18

New Annex 4

New Annex 5

Reference to Annex 18 of EC GMP

Guide

2003年9月1日 · PE 009-1

1 September 2003 · PE 009-1

修订附录1（主要是第3节）

Amendment of Annex 1 (mainly

section 3)

2004年7月1日 · PE 009-2

1 July 2004 · PE 009-2

修订附录13

更改编者联系信息

Revision of Annex 13

Change in the Editor’s co-ordinates

2006年1月1日 · PE 009-3

1 January 2006 · PE 009-3

修订第1章

Revision of Chapter 1

2006年6月1日 · PE 009-4

1 June 2006 · PE 009-4

修订第6章

Revision of Chapter 6

2006年8月1日 · PE 009-5

1 August 2006 · PE 009-5

对第6章修订的勘误

修订第8章

Corrections to revision of Chapter 6

Revision of Chapter 8

2007年4月5日 · PE 009-6

5 April 2007 · PE 009-6

将PIC/S GMP指南重组为第一部分、第二部分及附录

将PE 007（原料药指南）纳入为第二部分

新增附录19

修订引言

更改编者联系信息

Reorganisation of the PIC/S GMP

Guide in Part I, Part II and Annexes

Incorporation of PE 007 (APIs guide)

as Part II

New Annex 19

Revision of the Introduction

Change in the Editor’s co-ordinates

2007年9月1日 · PE 009-7

1 September 2007 · PE 009-7

修订总引言（“历史”部分）及第二部分引言

删除第一部分第6章及附录13中的脚注

Revision of General Introduction

(“History”) and Introduction to Part II

Deletion of footnotes in Chapter 6

(Part I) and Annex 13

2009年1月15日 · PE 009-8

15 January 2009 · PE 009-8

修订第一部分第1章

修订附录1

新增附录20

Revision of Chapter 1 (Part I)

Revision of Annex 1

New Annex 20

2009年9月1日 · PE 009-9

1 September 2009 · PE 009-9

修订附录3

Revision of Annex 3

2013年1月1日 · PE 009-10

1 January 2013 · PE 009-10

修订第一部分第4章

修订附录6、7、11和13

Revision of Chapter 4 (Part I)

Revision of Annex 6, 7, 11 and 13

2014年3月1日 · PE 009-11

1 March 2014 · PE 009-11

在PIC/S GMP指南第二部分引入质量风险管理（QRM）原则

修订附录2和14

Introduction of QRM principals in

PIC/S GMP Guide – Part II

Revision of Annex 2 and 14

2015年10月1日 · PE 009-12

1 October 2015 · PE 009-12

修订附录15

Revision of Annex 15

2017年1月1日 · PE 009-13

1 January 2017 · PE 009-13

修订第一部分第1、2、6和7章

Revision of Chapters 1, 2, 6 & 7

(Part I)

2018年7月1日 · PE 009-14

1 July 2018 · PE 009-14

修订第一部分第3、5和8章

修订附录17

Revision of Chapters 3, 5 & 8 (Part I)

Revision of Annex 17

2021年5月1日 · PE 009-15

1 May 2021 · PE 009-15

修订附录2

Revision of Annex 2

2022年2月1日 · PE 009-16

1 February 2022 · PE 009-16

修订附录13

新增附录16

Revision of Annex 13

New Annex 16

2023年8月25日 · PE 009-17

25 August 2023 · PE 009-17

修订附录1

Revision of Annex 1

2026年9月24日 · PE 009-18

24 September 2026 · PE 009-18

修订附录19

Revision of Annex 19

后续还会更新 Part I 制剂 GMP、Part II 原料药 GMP 及附录卷的中英双语完整版，点个关注 + 设为星标，别错过。

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