Annex 13 des eu-gmp-leitfadens






EUROPEAN COMMISSION Brussels 03 February 2010 EudraLex

3 févr. 2010 EU Guidelines to. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 13. Investigational Medicinal Products.
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Ausgabe von Makrolog www.recht.makrolog.de

2 avr. 2019 Anhang 13 zum EU-Leitfaden der Guten Herstellungspraxis. Prüfpräparate. Dokumentenhistorie. Februar 2008: Überarbeitung zur Bestärkung des ...
Annex


Draft Annex 15 - V12 200115 - for PICS and EC adoption

30 mars 2015 EU Guidelines for. Good Manufacturing Practice for. Medicinal Products for Human and Veterinary Use. Annex 15: Qualification and Validation.
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Annex 11: Computerised Systems

This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal products as laid down 





Annex 11: Computerised Systems

11 janv. 2011 This document provides guidance for the interpretation of the principles and guidelines of good manufacturing practice (GMP) for medicinal ...
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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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Annex 16: Certification by a Qualified Person and Batch Release

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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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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EUROPEAN COMMISSION Brussels 16.2.2022 C(2022) 843 final

16 févr. 2022 Volume 4 EU Guidelines for Good Manufacturing Practice for ... Guide and Annex 13 the detailed guidelines on GMP for Investigational.


EUROPEAN COMMISSION Brussels 25 November 2008 (rev

25 nov. 2008 EU Guidelines to. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex 1. Manufacture of Sterile Medicinal ...
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  1. annex 13 eu gmp leitfaden
  2. annex 13 des eu-gmp-leitfadens