september 21, 2022
Published by Joachim Nuyttens at september 21, 2022
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What’s in the new Eudralex Annex 1

A few weeks back the new and final version of Eudralex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” was published on the website of the European Commission. This new version will come into operation on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. Where the current version of Eudralex Volume 4 Annex 1 is 16 pages, the new version has no less than 59 pages. The new EU annex 1 regulation provides […]
augustus 31, 2021
richtlijnen
Published by Joachim Nuyttens at augustus 31, 2021
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Audit trail vereisten voor GxP computersystemen

Wikipedia definieert een audit trail als volgt: a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. Het eerste gebruik van audit trails dateert van de grote beschavingen uit de oudheid, wanneer eenvoudige methodes ontstonden om goederen, soldaten en financiële transacties op te volgen. Audit trails om data integriteit te borgen kregen in de farmaceutische industrie pas echt aandacht wanneer de US / FDA richtlijn 21CFR […]