FDA recently published its “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing Guidance for Industry” (“Guidance ...
Sphere Fluidics, a company developing single cell analysis systems underpinned by its patented picodroplet technology, today announced updates to its flagship platform, Cyto-Mine ®, enabling it to be ...
Leading Contract Supplement Manufacturer Welcomes The Higher Standards And Consumer Confidence That Will Come With These Long Awaited Manufacturing Regulations (PRWEB) June 20, 2010 -- Leading ...
The Food and Drug Administration (FDA) issued a Final Rule to amend device current good manufacturing practices (CGMP) requirements of the Quality System (QS) regulation to harmonize the requirements ...
Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This ...
Dublin, July 17, 2025 (GLOBE NEWSWIRE) -- The "Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Training Course" training has been added to ...
All CGMP requirements, including supporting activities, are critical in aseptic sterile manufacturing to ensure product quality and patient safety, says Susan J. Schniepp, distinguished fellow at ...
Facility design should integrate risk mitigation strategies, focusing on contamination prevention and reliable utility ...