人用药物注册技术要求国际协调会议( I C H ：International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human U)
ICH三方协调指南
原料药的优良制造规范（GMP）指南
ICH指导委员会2000年11月10日按ICH规程第4步建议采用
本指南根据ICH规程由合适的ICH专家工作组起草并经向法规部门咨询。在规程的第4步，建议欧洲共同体、日本和美国的药政部门采用其最终的草案。
原料药的优良制造规范（GMP）指南
ICH三方协调指南
ICH指导委员会2000年11月10日的会议按ICH规程第4步
建议ICH的三个药政部门采用本指南
原料药的优良制造规范(GMP) 指南
Guidance for Industry
Q7A Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients
This guidance reprents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be ud if such approach satisfies the requirements of the applicable statutes and regulations.
1 引言INTRODUCTION
1.1 目的Objective
本文件(指南)旨在为在合适的质量管理体系下制造活性药用成分(原料药以下称原料药)提供有关优良药品生产管理规范（GMP）提供指南。它也着眼于帮助确保原料药符合其旨在达
到或表明拥有的质量与纯度要求。 (This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are reprented, to posss.)
本指南中所指的“制造”包括物料接收、生产、包装、重新包装、贴签、重新贴签、质量控制、放行、原料药的储存和分发及其相关控制的所有操作。在本指南中，“应当”一词表示希望采用的建议，除非证明其不适用或者可用一种已证明有同等或更高质量保证水平的供选物来替代。本指南中的“现行优良生产管理规范(cGMP)”和“优良生产管理规范(GMP)”是等同的。 (In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, relea, storage and distribution of APIs and the related controls. In this guidance, the term should identifies recommendations that, when followed, will ensure compliance with CGMPs. An alternative approach may be ud if such approach satisfies the requirements of the applicable statutes. For the purpos of this guidance, the terms
current good manufacturing practices and good manufacturing practices are equivalent.)
本指南在总体上未涉及生产人员的安全问题，亦不包括环保方面的内容。这方面的管理是生产者固有的责任，也是国家法律规定的。 (The g梦见气球
uidance as a whole does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. The controls are inherent responsibilities of the manufacturer and are governed by national laws.)
本指南没打算规定注册/归挡的要求、或修改药典的要求。本指南不影响负责药政审理部门在原料药上市/制造授权或药品申请方面建立特定注册/归挡要求的能力。注册/归挡的所有承诺必须做到。(This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeias requirements. This guidance does not affect the ability of the responsible regulatory agency to establish specific registration/filing requirements regarding APIs within the context of marketing/manufacturing authorizations or drug applications. All commitments in registration/filing documents should be met. )
1.2 法规的适用性 Regulatory Applicability
在世界范围内对原料药的法定定义是各不相同的。当某种物料在其制造或用于药品的地区或国家被称为原料药，就应该按照本指南进行生产。(Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or ud in a drug product, it should be manufactured according to this guidance.)
1.3 范围 Range
本文件适用于人用药品（医疗用品）所含原料药的制造。它适用于无菌原料药在灭菌前的步骤。本指南不包括无菌原料药的消毒和灭菌工艺，但是，应当符合地方当局所规定的药品(医疗用品)生产的GMP指南。
本文件适用于通过化学合成、提取、细胞培养/发酵，通过从自然资源回收，或通过这些工艺的结合而得到的原料药。通过细胞培养/发酵生产的原料药的特殊指南则在第18章论述。 (This guidance applies to the manufacture of APIs for u in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aptic processing of sterile
APIs are not covered by this guidance, but should be performed in accordance with GMP guidance for drug (medicinal) products as defined by local authorities. This guidance covers APIs that are manufactured by chemical synthesis, extraction, cell culture/fermentation, recovery from natural sources, or any combination of the process. Specific guidance for APIs manufactured by cell culture/fermentation is described in Section XVIII (18).)
