In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines that will ...
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 ...
The "How to Interview During GMP (Good Manufacturing Practice) Audits Training Course (Mar 12, 2026)" training has been added to ResearchAndMarkets.com's offering. Ensuring compliance with Good ...
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 ...
Proactive maintenance using digital tools and AI enhances GMP compliance, operational efficiency, and regulatory credibility. Facility design should integrate risk mitigation strategies, focusing on ...
Indian medical device manufacturers are enhancing their Good Manufacturing Practice (GMP) compliance, reinforcing India's role as a trusted global supplier in the healthcare and MedTech sectors. This ...
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