EUROPEAN COMMISSION Brussels 03 February 2010 EudraLex
3 fév. 2010 EU Guidelines to. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 13. Investigational Medicinal Products.
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guide to good manufacturing practice for medicinal products annexes
1 fév. 2022 Annex 13 (Manufacture of investigational medicinal products) ... be applied in conjunction with PIC/S GMP guidelines and annexes. It has ...
Health Products and Food Branch Inspectorate
Guidance Document - Annex 13 Current Edition of GMP Guidelines Drugs Used In Clinical Trials (GUI-0036) / Dec 1 2009. Page 2 of 25. Table of Contents.
GUI eng
Annex 19 Reference and Retention Samples
14 déc. 2005 EU Guidelines to. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 19. Reference and Retention Samples.
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Draft Annex 15 - V12 200115 - for PICS and EC adoption
30 mar. 2015 EU Guidelines for. Good Manufacturing Practice for. Medicinal Products for Human and Veterinary Use. Annex 15: Qualification and Validation.
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Final version sent to EC
12 oct. 2015 EU Guidelines for. Good Manufacturing Practice for. Medicinal Products for Human and Veterinary Use. Annex 16: Certification by a Qualified ...
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EUROPEAN COMMISSION Brussels 16.2.2022 C(2022) 843 final
16 fév. 2022 Volume 4 EU Guidelines for Good Manufacturing Practice for ... Guide and Annex 13 the detailed guidelines on GMP for Investigational.
Annex 16: Certification by a Qualified Person and Batch Release
12 oct. 2015 This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal ...
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EU Good Manufacturing Practice ANNEX 13 Investigational
laid out in Annex 13 of the EU GMP guidelines. This annex details guidance for Investigational Medicinal Products. (IMPs) and this handbook will focus only
EU Good Manufacturing Practice ANNEX Investigational Medicinal Products
Annex 11: Computerised Systems
provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down in
- annex 13 gmp guidelines
- annex 13 eu gmp guidelines