Transcription of GUIDE TO GOOD MANUFACTURING PRACTICE …
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GUIDE TO GOOD MANUFACTURING PRACTICE …
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 009-8 (Part II) 15 January 2009 PE 009-8 (Part II) 15 January 2009 GUIDE TO good MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART II Developed by the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use PIC/S January 2009 Reproduction prohibited for commercial purposes. Reproduction for internal use is authorised, provided that the source is acknowledged. Editor: PIC/S Secretariat 14 rue du Roveray CH-1207 Geneva e-mail: web site: PE 009-8 (Part II) - i - 15 January 2009 TABLE OF CONTENTS Page 1.
Introduction PE 009-8 (Part II) - 1 - 15 January 2009 1. INTRODUCTION 1.1 Objective This document (Guide) is intended to provide guidance regarding good manufacturing
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