EUROPEAN COMMISSION Brussels 25 November 2008 (rev
25/11/2008 Medicinal Products for Human and Veterinary Use. Annex 1. Manufacture of Sterile Medicinal Products. (corrected version). Document History.
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guide to good manufacturing practice for medicinal products annexes
1/02/2022 Annex 1 (Manufacture of sterile medicinal products). 1. Principle. 1 ... Annex 17 (Real Time Release Testing and Parametric Release).
PIC/S GMP Guide Annex 1 - Manufacture of sterile medicinal products
Annex 1 was last revised in the release of PIC/S 009-08 in January. 2009. • PIC/S 009-08 was the version adopted by TGA until 31 Dec 2017. (and still being
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Annex 1 : Manufacture of Sterile Products Document map Section
are stored and maintained in accordance with the registered storage conditions. 154. 155 vii. Persons responsible for the quality release of sterile products
EUROPEAN COMMISSION Brussels 25 November 2008 (rev
25/11/2008 Medicinal Products for Human and Veterinary Use. Annex 1. Manufacture of Sterile Medicinal Products. (corrected version). Document History.
EU GMP Annex Glossary
Compilation of Union Procedures on Inspections and Exchange of
1/08/2010 Annex 1 includes specific provisions for product related inspections of manufacturers and importers of medicinal products;.
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Guide to Good Manufacturing Practice for Medicinal Products
1/07/2018 Annex 1 (Manufacture of sterile medicinal products). 1. Principle. 1 ... Annex 17 (Real Time Release Testing and Parametric Release).
pe gmp guide annexes
Annex 16: Certification by a Qualified Person and Batch Release
12/10/2015 as amended on the Community code relating to medicinal products for human ... 1.4.1 Where the site only undertakes partial manufacturing ...
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EudraLex The Rules Governing Medicinal Products in the European
22/11/2017 guidelines on good manufacturing practice specific to advanced therapy medicinal products ("ATMPs"). Article 63(1) of Regulation (EU) No ...
PICS GMP Guide (Annexes)
1/07/2018 Annex 1 (Manufacture of sterile medicinal products). 1. Principle. 1 ... Annex 17 (Real Time Release Testing and Parametric Release).
PE GMP Guide Annexes
- annex 1 manufacture of sterile medicinal products (corrected version)