Transcription of Q 7 Good Manufacturing Practice for Active …
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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 Qualific
This document (Guide) is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements
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