Transcription of Compilation of Union Procedures on Inspections and ...
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Compilation of Union Procedures on Inspections and ...
EUROPEAN COMMISSION. HEALTH AND FOOD SAFETY DIRECTORATE-GENERAL. Health systems, medical products and innovation Medical products: quality, safety, innovation 21 September 2021. EMA/INS/428126/2021 Rev 18. Inspections Office, Quality and Safety of Medicines Department Compilation of Union Procedures on Inspections and Exchange of Information This document forms part of the Compilation of Union Procedures on Inspections and Exchange of Information. Please check for updates on the European Medicines Agency's website. Published in Agreement with the European Commission by the European Medicines Agency Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 An agency of the European Union European Medicines Agency, 2021. Reproduction is authorised provided the source is acknowledged. Table of Contents: Introduction .. 4. Part I Procedures .. 5.
EN ISO/IEC 17020:2005 General criteria for the operation of various types of bodies performing inspections; EN ISO/IEC 17023:2006 General requirements for bodies operating assessment and certification/ registration of quality system;
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