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GUIDE TO GOOD MANUFACTURING PRACTICE FOR …
PHARMACEUTICAL INSPECTION CONVENTION PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME PE 009-8 (Part I) 15 January 2009 PE 009-8 (Part I) 15 January 2009 GUIDE TO good MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS PART I 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 I) - i - 15 January 2009 TABLE OF CONTENT chapter 1 - QUALITY 1 1 Quality 1 good MANUFACTURING PRACTICE for Medicinal products (GMP).. 2 Quality 3 Product Quality 4 Quality Risk 5 chapter 2 - 7 7 7 Key Personnel.
Chapter 1 Quality Management PE 009-8 (Part I) - 1 - 15 January 2009 CHAPTER 1 QUALITY MANAGEMENT PRINCIPLE The holder of a manufacturing authorisation must manufacture medicinal
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