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When it comes to current good manufacturing practice (cGMP) inspections, risk management practices are dictating everything from how the inspection is conducted to who is placed on the investigative team, according to FDA officials.
Risk management plays a critical role in determining an investigator’s approach to a current good manufacturing practice (cGMP) inspection, dictating everything from how the inspection is conducted to who is placed on the investigative team, FDA officials told a recent industry conference.
GlaxoSmithKline (GSK) expects to begin resupplying the U.S. and foreign markets with Paxil CR and Avandamet by midyear after reaching a consent decree agreement with the FDA regarding manufacturing violations at its Cidra, Puerto Rico, plant.
Risk management plays a critical role in determining an investigator's approach to a current good manufacturing practice (cGMP) inspection, dictating everything from how the inspection is conducted to who is placed on the investigative team, FDA officials told a recent industry conference.
GlaxoSmithKline (GSK) has reached a consent decree agreement with the FDA on manufacturing violations at GSK’s Cidra, Puerto Rico, plant that will allow the firm to begin resupplying the U.S. and foreign markets with Paxil CR and Avandamet by midyear.
GlaxoSmithKline (GSK) expects to begin resupplying the U.S. and foreign markets with Paxil CR and Avandamet by midyear after reaching a consent decree agreement with the FDA regarding manufacturing violations at its Cidra, Puerto Rico, plant.
The FDA has sent a warning letter to Tosoh Bioscience alleging the operations at the company’s San Francisco facilities, where immunoassay diagnostic packs and immunoassay systems are relabeled and repackaged, do not conform to cGMP requirements.
The FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued AstraZeneca its second untitled letter in four months regarding promotional activities for the company’s cholesterol-lowering drug Crestor.
The FDA has issued a warning letter to custom chemical company DanChem for failing to meet current good manufacturing practices (cGMPs) in its production of active pharmaceutical ingredients (APIs).
U.S. drug manufacturers looking to lower development costs by contracting with Chinese firms for active pharmaceutical ingredients (APIs) need to do so carefully, according to an industry expert, who warned that such partnerships are not always cost-effective.