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In the wake of a rash of infant deaths related to GMP-certified hepatitis B vaccines, China is renewing its push to have makers of vaccines, blood products and sterile injectables obtain a revised good manufacturing practice certificate. Read More
Active pharmaceutical ingredient (API) manufacturers operating in Canada must establish clearly defined and controlled manufacturing processes to ensure consistency under Health Canada’s newly finalized good manufacturing practices (GMP) guidelines. Read More
The FDA has upgraded the status of Hospira’s troubled Rocky Mount, N.C., manufacturing plant to allow it to begin using the facility to manufacture new products. Read More
The Pharmaceuticals and Medical Devices Agency is asking drugmakers to submit information on stability monitoring and water purity when they apply for mandatory postapproval good manufacturing practice inspections. Read More
Drugmakers should clearly define their validation activities in a validation master plan that accounts for the lifecycle of a product and related plant equipment, the European Commission says. Read More
The FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drugmakers’ manufacturing facilities. Read More
CDER plans to issue highly anticipated guidance in 2014 that addresses specifics about its biosimilars approval pathway and sheds some light on social media usage for pharma companies. Read More
To discourage GMP scofflaws, the European Medicines Agency is now publicly naming drugmakers that aren’t in line with current good manufacturing practices. Read More
Unresolved investigations into bottling and packaging operations and insect problems have landed one of Sandoz’s U.S. facilities a Form 483. During an October inspection of Sandoz’s Broomfield, Colo., facility, investigators found spiders, centipedes and moths. Read More