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July 10, 2014
FDA clarifies GDUFA requirements in regards to abbreviated new drug applications and prior approval supplements.
July 02, 2014
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to ensure data integrity.
Nitrogen dioxide can sterilize and depyrogenate an aseptic fill area in a blow-fill-seal process.
July 01, 2014
FDA releases guidance documents and rules on requirements for compounding human drug products.
European Medicines Agency clarifies advanced-therapy medicinal products classification.
Bristol-Myers Squibb issues a voluntary US recall of Coumadin (warfarin sodium) for injection due to presence of particulate matter.
June 26, 2014
GSK Biologicals receives warning about cGMP compliance issues at its Quebec facility.
June 18, 2014
FDA cites cGMP violations for API manufacturing at a facility in Tianjin, China.
FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.