The case for migrating from a paper-based quality management system to a digital platform is presented. 3DKOMBINAT - STOCK.ADOBE.COM In 2019, the failure to document quality responsibilities and ...
The FDA has issued new guidelines that exempt Phase I drugs from certain Good Manufacturing Practice regulations. In issuing the exemptions--which go into effect September 15, the agency notes that ...
Drug manufacturers need to work closely with excipient suppliers to ensure supply chain safety. ramcreations/shutterstock.com Recently adopted regulations in the ...
Dublin, Nov. 05, 2025 (GLOBE NEWSWIRE) -- The "Data Integrity in GMP and GCP: Compliance with FDA, EMA, and MHRA Requirements (Oct 7, 2025)" training has been added to ResearchAndMarkets.com's ...
Establishing a lab in biopharmaceutical fields such as cell and gene therapies can be demanding, requiring swift and efficient setup while meeting rigorous regulatory standards. The FDA's Good ...
Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in ...
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 ...
Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in ...
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