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March 04, 2019
The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
March 02, 2019
Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.
February 25, 2019
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.
February 20, 2019
The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.
February 06, 2019
The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.
The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.
February 02, 2019
Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.
Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
Policies emphasize the importance of ensuring data integrity in the United States and abroad.
February 01, 2019
A look at some best practices to ensure that quality control is maintained in the client–vendor relationship.