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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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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Annex 11: Computerised Systems
The Rules Governing Medicinal Products in the European Union. Volume 4. Good Manufacturing Practice. Medicinal Products for Human and Veterinary Use. Annex
Guideline on the sterilisation of the medicinal product active
6 mars 2019 (EMEA/CVMP/065/99) which is an annex to the note for guidance: ... into account the specific requirements of Annex 1 of EU GMP-Guidelines.
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Annex 1 : Manufacture of Sterile Products Document map Section
The intent of the Annex is to provide guidance for the manufacture of sterile to the relevant sections of the Good Manufacturing Practices (GMP) guide.
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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guide to good manufacturing practice for medicinal products annexes
1 févr. 2022 Part A: General guidance. 24. Supplimentary provisions to PIC/S GMP Guide Part I. 25. Chapter 1 Pharmaceutical quality system.
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 1 1 Manufacture of Sterile Medicinal Products 2 Document
20 déc. 2017 according to Annex 11 and Annex15 of EU GMP. ... Note 1: 112. This guidance does not lay down detailed methods for determining the ...
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gmp annex 1 draft (version 12) implementation timing example 4.23
25 mai 2021 They should not be considered as industry guidance on ... revised EU GMP Annex 1 draft (version 12) as written as reflected in the industry ...
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- eu gmp annex 1 draft pdf
- eu gmp annex 1 2020 pdf
- eu gmp annex 1 2008 pdf
- eu gmp annex 1 revision 2021 pdf
- eu gmp annex 1 2017 pdf
- eu gmp annex 1 revision 2020 pdf
- eu gmp annex 1 revision 2008 pdf
- eu gmp annex 1 revision 2018 pdf