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It is important to understand the differences between risk-based decision making and other decision making in a pharmaceutical quality system.
Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.
Quality-by-design risk assessment workflows can be laborious and have limited capacity to connect with vast volumes of prior knowledge generated by organizations. ecosystem.
July 02, 2019
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?
Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.
July 01, 2019
FDA is collecting public comments on a draft guidance for bioanalytical method validation developed by ICH.
FDA approved first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system.
More than 30 lots of losartan drug products have been recalled due to contaminated API manufactured by Hetero Labs.
June 28, 2019
Three months following his departure from FDA, former commissioner Scott Gottlieb joins Pfizer’s board of directors.
June 25, 2019
The US Senate and the US Pharmacopeial Convention debate the necessity of monographs for biologics.
June 24, 2019
The biosimilar, Kanjinti, is approved for all indications of Herceptin, which includes treating breast, gastric, and gastroesophogeal cancers.
Using Lean, Six Sigma, and other Op Ex practices is helping one contract development and manufacturing organization (CDMO) increase efficiency and optimization.
June 20, 2019
FDA sent a warning letter to Spectrum Laboratory Products, Inc. after an inspection found CGMP and misbranding violations.