Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...
EU good manufacturing practice (GMP) Annex 11 regulation on computerized systems has been effective since 1992. 1 Following the data falsification uncovered at Able Laboratories in 2005, 2 many data ...
In March 2025, the European Medicines Agency (EMA) published a three-year work plan (2025–2027) for the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group (IWG), focusing on ...
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 ...
Industry can apply for WHO GMP CoPP while product license is under consideration of SLA: Gireesh Babu, New Delhi Tuesday, October 7, 2025, 08:00 Hrs [IST] After mandating that the ...
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