The FDA updated its staff manual on Chemistry, Manufacturing and Controls reviews of drug master files for packaging materials. Source: Drug GMP Report

The European Medicines Agency’s pharmacovigilance panel made recommendations for updated label warnings for a variety of products. Source: Drug GMP Report

Shortcomings in sterile drug processing landed three companies in trouble with the FDA, while a fourth was chastised for neglect of a customer’s complaint, as reflected in Form 483 inspection…

Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at…

The European Medicines Agency said it may become more difficult for UK firms to have GMP non-compliance statements lifted following Brexit. Source: Drug GMP Report

The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Source: Drug GMP Report

Makers of compounded drugs, dietary supplements and OTC treatments, at home and abroad, drew warning letters from the FDA. Source: Drug GMP Report

CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Source:…

The FDA cited two compounders and two drugmakers for failure to maintain aseptic conditions and for other shortcomings, as reflected in Form 483 inspection reports. Source: Drug GMP Report

A federal judge shut down a Salt Lake City drug compounder Aug. 3 under a consent decree issued in a case brought by the FDA after inspections uncovered numerous regulatory…