Q 7 Good Manufacturing Practice for Active …

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: Date for coming into operation for this guideline will be released by the European Commission, DG Enterprise, Unit for Pharmaceuticals ( ). EMEA 2006 2 good Manufacturing Practice FOR Active pharmaceutical ingredients TABLE OF CONTENTS Section Title 1 Introduction Objective Regulatory Applicability Scope 2 Quality Management Principles Responsibilities of the Quality Unit(s) Responsibility for Production Activities Internal Audits (Self-Inspection) product Quality Review 3 Personnel Personnel Qualifications

Good Manufacturing Practice for Active Pharmaceutical Ingredients ... The sterilization and aseptic processing of sterile APIs are not covered by ... (medicinal) products, and manufacturing/control aspects specific to radiopharmaceuticals. Section 19 contains guidance that only applies to the manufacture of APIs used in the production of drug ...

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  Product, Good, Practices, Pharmaceutical, Manufacturing, Active, Ingredients, Active pharmaceutical ingredients, Aseptic, Q 7 good manufacturing practice

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