OR WAIT null SECS
September 29, 2014
Quality is a matter of culture more than metrics. In this opinion article, the author presents arguments for an FDA Dean's List as a means to nurture a quality culture within the industry.
September 16, 2014
FDA releases guidance on ANDAs and PASs submissions to help applicants avoid deficiencies.
September 04, 2014
Meggle Group Wasserburg has been granted an EXCiPACT certificate.
September 01, 2014
Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.
August 20, 2014
FDA found violations of cGMP at finished-drug manufacturer in India.
August 02, 2014
The latest revisions to the USP General Chapters Balances and Weighing on an Analytical Balance aim to ensure weighing accuracy and eliminate unnecessary overtesting by simplifying previous descriptions and reflecting current state-of-the-art weighing practices.
July 17, 2014
Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.
July 16, 2014
Trifarma cited for significant deviations in data collection and security, and employee training.
July 11, 2014
Sun Pharma, Forest Pharmaceuticals and West-Ward Pharmaceuticals issue recalls over dissolution issues.
Baxter Healthcare has initiated a nationwide recall of more than 20,000 containers of a pre-mixed beta blocker due to the presence of particulate matter.