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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 .. 7 Training .. 9 Personal Hygiene .. 9 CHAPTER 3 - PREMISES AND 11 11 11 11 Production 11 Storage 13 Quality Control 13 Ancillary 14 Equipment .. 14 CHAPTER 4 - DOCUMENTATION ..15 15 15 Documents required .. 16 Specifications.
pharmaceutical inspection convention pharmaceutical inspection co-operation scheme pe 009-8 (part i) 15 january 2009 pe 009-8 (part i) 15 january 2009
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