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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

Reproduction prohibited for commer车澈个人资料 cial purpos.

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TABLE OF CONTENTS目录 &2022考研时间 nbsp;

1. Document History 文件历史

2. Introduction 介绍

3. Purpo 目的

4. Scope 范围

5. Aide-Memoire&n是我不够勇敢 bsp;备忘

6. R什么笔不能写 evision History 修订历史

&n荷叶的功效 bsp;

1. DOCUMENT 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 medicines.

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