Transcription of Q 7 Good Manufacturing Practice for Active Pharmaceutical ...
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Q 7 Good Manufacturing Practice for Active Pharmaceutical ...
European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged November 2000 CPMP/ICH/4106/00 ICH Topic Q 7 Good Manufacturing Practice for Active Pharmaceutical ingredients Step 5 NOTE FOR GUIDANCE ON GOOD Manufacturing Practice FOR Active Pharmaceutical ingredients (CPMP/ICH/4106/00) TRANSMISSION TO CPMP July 2000 RELEASE FOR CONSULTATION July 2000 DEADLINE FOR COMMENTS September 2000 SUBMISSION TO CPMP FOR INFORMATION November 2000 RELEASE FOR INFORMATION November 2000 Note.
© EMEA 2006 2 GOOD MANUFACTURING PRACTICE FOR ACTIVE PHARMACEUTICAL INGREDIENTS TABLE OF CONTENTS Section Title 1 Introduction 1.1 Objective
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Pharmaceuticals and medical devices sector, Active pharmaceutical ingredients, Ingredients, STERILE PHARMACEUTICAL, Stability testing of pharmaceutical products, Pharmaceutical, Microbiology and Auditing, PDA Draft Technical Report No. 29, Food and drug administration, Compliance program guidance manual