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Search results with tag "Gmp annex 1"
EU GMP Annex 1: Manufacture of Sterile Medicinal Products
www.rssl.comThe new version of EU GMP Annex 1 was issued on 22nd August 20221, addressing the manufacture of sterile products. This is a legally binding part of EU GMP (as per Article 47 of Directive 2001/83/EC on the Community code relating to medicinal products for human use of the European Union).
Best Practice for Clean Room Monitoring - BCW
www.bcw.beBest Practice for Clean Room Monitoring. Guidance on clean room monitoring with reference to EU-GMP Annex 1 and ISO 14644 Part 1:2015 & ISO14644 Part 2:2015