FDA Drug GMP Warning Letters Increase 6%, Focus on Supply Chain and Sterility Assurance in FY 2011 / The number of drug GMP warning letters issued by FDA continued to climb in fiscal year 2011, with supply chain and sterility assurance issues dominating the agency’s attention. FDA is requesting a budget increase in FY 2013 to expand its inspectional presence abroad to better meet global supply chain threats, and agency officials are saying that failure to monitor contract manufacturers is a major problem shown in recent warning letters, but that failure to investigate out-of-specification results is still the No. 1 finding. / “The Gold Sheet” April 2012

FDA Drug GMP Warning Letters from FY 2011 / This listing of all 52 drug cGMP warning letters FDA sent in fiscal year 2011 groups them by dosage form, and describes the issues each one addressed. / “The Gold Sheet” April 2012

As ICH Q3D Metal Impurity Limits Near, Industry Worries What New Tests May Find / With ICH planning to propose Q3D metal impurity limits in June and USP requiring new metals test methods soon thereafter, pharmaceutical companies are wondering whether any of their ingredients might fail the tests, perhaps requiring them to reformulate products or suspend production. Early indications from FDA and industry testing are largely reassuring, while highlighting some areas for further inquiry. / “The Gold Sheet” April 2012

Legislation in Brief / The Senate user fee bill may get industry’s version of track-and-trace or FDA’s or neither, but certainly would free FDA from inspecting facilities every two years. Meanwhile, Congress keeps generating ideas for combating drug shortages. / “The Gold Sheet” April 2012

FDA Studies In Brief / FDA studies why patients can’t switch among bioequivalent antiepileptics, how potentially biosimilar protamine sulfates vary, which firms pose the greatest drug import/export risks, how to evaluate quality management systems and how to get more results oriented. / “The Gold Sheet” April 2012