q7a(中英文对照)gmpguidanceforapis(fda原料药gmp指南)

　Q7a

　（中英文对照）

　GMP Guidance for APIs

　（ FDA 原料

　药 GMP 指南）

　 

　1. INTRODUCTION

　 

　简介   1.1 Objective

　 

　1.1 目的  

　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 represented, to possess.

　 

　本文件旨在为在合适的质量管理体系下制造活性药用成分

　（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。

　 

　 

　 

　In this guidance, the term manufacturing is defined to include all operations of receipt of materials, production, packaging, repackaging, labeling, relabeling, quality control, release, 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 used if such approach satisfies the requirements of the applicable statues. For the purposes of this guidance, the terms current good manufacturing practices and good manufacturing practices are equivalent.

　 

　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。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。

　 

　 

　 

　The guidance as a whole does not cover safety aspects for the personnel engaged in manufacturing, nor aspects related to protecting the environment. These controls are inherent responsibilities of the manufacturer and are governed by national laws.

　 

　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。

　  

　 

　 

　This guidance is not intended to define registration and/or filing requirements or modify pharmacopoeial 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.

　 

　本指南未规定注册

　/归档的要求、 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

　/归档要求的能力。注册

　/归档的所有承

　诺必须做到。

　  

　 

　 

　1.2 Regulatory Applicability

　 

　1.2 法规的适用性  

　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 used in a drug product, it should be manufactured according to this guidance.

　 

　在世界范围内对原料药的法定定义是各