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20090113 PI 030-1 PICS 原料药检查备忘(中英文)

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20090113 PI 030-1 PIC/S 原料药检查备忘

PHARMACEUTICAL INSPECTION CONVENTION

PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME

PI 030-1

13 January 2009

AIDE-MEMOIRE 备忘

INSPECTION OF ACTIVE PHARMACEUTICAL INGREDIENTS

原料药检查

? PIC/S January 2009

Rep包装设计展开图 roduction prohibited for commercial purpos.

Reproduction for internal u is authorid, provided that the source is acknowledged.

TABLE OF CONTENTS目录

1. Document History 文件历史

2. Introduction&水果羹 nbsp;介绍

3. Purpo 目的

4. Scope 范围

5. Aide-Memoire 备忘

6. Revision History 修订历史

1. DO入门玄关 CUMENT HISTORY 文件历史

Adoption by Committee 被委员会采用	12.11.2009
Entry into force of PI 030-1 实施	01.03.2009

2. INTRODUCTION 介绍

2.1 The adoption of ICH Q7 as the first truly harmonid GMP guideline for active pharmaceutical ingredients (APIs) and the associated development of regulatory frameworks to implement the guideline as a regulatory standard mark the beginning of a new era of regulation for 茶花女读后感 medicines.

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