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November 15, 2014
Advanced analytical methods are speeding up the targeted evaluation of potential viral contaminants.
November 04, 2014
An FDA warning letter to Hikma Pharmaceuticals cites violations of CGMP at its plant in Portugal that manufactures finished drugs.
October 30, 2014
Gerresheimer, a company with expertise in pharmaceutical and medical technology, announced that it is applying an integrated mold qualification and validation concept for a fast and cost-efficient time-to-market. The company notes that this approach provides process windows for reliable large-scale production and offers options for different deployment scenarios and qualification levels.
September 17, 2014
Understanding how to identify, remediate, and prevent facility infection is crucial for product quality.
September 04, 2014
Meggle Group Wasserburg has been granted an EXCiPACT certificate.
August 20, 2014
FDA found violations of cGMP at finished-drug manufacturer in India.
July 17, 2014
Baxter investigates root cause of cellulosic fibers and/or plastics in four lots of IV solutions.
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.
July 02, 2014
The authors look at the cleanability of pharmaceutical soils from a variety of materials of construction to determine the relative ease of cleaning and explore potential grouping strategies as part of a comprehensive cleaning validation program.