Joanne S. Eglovitch
Senior Editor
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Latest From Joanne S. Eglovitch
In Pandemic Response, Quality Experts Advise Drug Manufacturers Move Products To Local Sites
AstraZeneca emptied its warehouses in January. “We said, OK let us pack everything and get it out in the door,” said Tony Mire-Sluis, head of global quality. The firm is allowing only crucial personnel in plants, or those responsible for running a plant or moving products; all others are working from home.
Quality Experts Advise Industry To Move Products To Local Sites In Responding To COVID-19
Quality experts with AstraZeneca and Thermo Fisher describe how their companies are responding to the COVID-19 pandemic – but urge industry not to lose focus on monitoring unrelated drug products.
FDA Warning Letters Hit Small OTC, Large Pharma Firms With Same Citations In FY 2019
Inadequate process controls and faulty failure investigations were the top GMP violations found in warning letters sent in FY 2019 to companies large and small.
Cipla Plant Gets FDA Warning Letter
Despite the stain on Cipla’s compliance record, the company leads on drug quality in India, with major concerns raised in only 3% of FDA inspections, compared to 11% generally.
US FDA Suspends Domestic Inspections As Staff Work Remotely In Covid-19 Response
Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent Covid-19, the disease caused by the virus, and breakthrough products such as cancer treatments.
API In Ducts And Filters Led To Cipla’s First Drug GMP Warning Letter
Despite the stain on Cipla’s compliance record, the company leads on drug quality in India, with major concerns raised in only 3% of FDA inspections, compared to 11% generally.