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1 févr. 2022 Annex 1 (Manufacture of sterile medicinal products). 1. Principle. 1 ... Annex 18 [GMP Guide for active pharmaceutical ingredients]**.
Annex 1 1 Manufacture of Sterile Medicinal Products 2 Document
20 déc. 2017 1 Scope. 6. 7. The manufacture of sterile medicinal products covers a wide range of product ... according to Annex 11 and Annex15 of EU GMP.
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Concept paper on the revision of annex 1 of the guidelines on good
This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) guide.
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Annex 1 : Manufacture of Sterile Products Document map Section
according to the relevant sections of the Good Manufacturing Practices (GMP) guide. 37. The use of appropriate technologies (e.g. Restricted Access Barriers
PIC/S GMP Guide Annex 1 - Manufacture of sterile medicinal products
Annex 1 – Manufacture of Sterile Medicinal Products. PI 032-2 GMP ANNEX 1 REVISION 2008 INTERPRETATION OF. MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF.
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GMP ANNEX 1 REVISION 2008 INTERPRETATION OF MOST
8 janv. 2010 The present technical interpretation of Annex 1 to the PIC/S GMP Guide (PE 009) on the manufacture of sterile medicinal products (hereinafter ...
Guide to Good Manufacturing Practice for Medicinal Products
1 juil. 2018 Annex 1 (Manufacture of sterile medicinal products). 1. Principle. 1 ... Annex 18 [GMP Guide for active pharmaceutical ingredients]**.
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Concept paper on the revision of annex 1 of the guidelines on good
5 févr. 2015 This concept paper addresses the need to update annex 1 (manufacture of sterile medicinal products) of the good manufacturing practice (GMP) ...
Guideline on the sterilisation of the medicinal product active
6 mars 2019 Requirements for the manufacture of sterile medicinal products and sterile components6. 4.1.1. ... 1 As defined in GMP Annex 1.
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