The 2023 revision of Annex 1 of the European Union’s good manufacturing practice (GMP) guidelines 1 represents a fundamental shift in expectations for sterile manufacturing. Reg ...
In this Pharma Matters Q&A, Amina Rahmoune of Nelson Labs evaluates and compares sterility testing in cleanrooms and isolators.
Learn how ready-to-use vials and cartridges can aid in GMP Annex 1 Implementation and streamline compliance with EU ...
In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...
Dublin, July 28, 2025 (GLOBE NEWSWIRE) -- The "New EU (European Union) GMP (Good Manufacturing Practice) Annex 1: Compliant Aseptic Operations Training Course" has been added to ResearchAndMarkets.com ...
This whitepaper by West Pharmaceutical Services explores how pharmaceutical manufacturers and suppliers can confidently navigate the revised EU GMP Annex 1 guidelines for sterile drug production. It ...
A new modification of the EU GMP Annex 1 regulatory standard for sterile drug products was announced in August 2022, substituting the most recent 2020 draft and the previous 2008 revision. The new ...
(MENAFN- Market Press Release) December 6, 2025 6:40 am - Pharmig India 2025 concludes with strong industry participation, reinforcing sterility, contamination control, and GMP excellence in pharma ...
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