Recently added articles from Validation Times:
Biopharmaceutical firms push harmonized audits to eliminate cost, duplication.(Inspections)
May 01, 2009; ... ATLANTA -- Biopharmaceutical manufacturers are eager for harmonized audits to avoid duplication of effort and save costs, which for some firms can be as high as $400,000 a day to achieve compliance in the U.S., EU and other nations with differing inspection approaches. ...
Proposed FY 2010 budget targets medical product and food safety.(FDA)
May 01, 2009; ... FDA has requested a 19% budget increase for fiscal year 2010 (Oct. 1, 2009 through Sept. 30, 2010), which would yield a $3.2 billion budget aimed primarily at food safety, but also with millions for drug, device and biologic safety and GMP compliance. More than $160 million will ...
FDA says knowledge of overseas operations is vital to secure supply chain.(Import Safety)
May 01, 2009; ... WASHINGTON -- Ensuring a safe supply chain is a complex, ongoing process, and some at FDA feel they're working without a complete set of tools. "As the world has gotten bigger and complexity has increased, we don't have adequate information about supply chains, including participants and ...
Cell source, reagents and validation key to FDA; Novocell, Lonza outline their methods.(Stem Cells)
May 01, 2009; ... ATLANTA -- Manufacturers seeking to market therapeutics from stem cells should focus their efforts on building quality into the product through the consistent control of cell source, reagents, facility, personnel and equipment, and the validation of manufacturing process, aseptic ...
Genentech has 2 QbD proposals to CDER as EMEA seeks ways to ease difficulties for biotech drugs.(Quality by Design)
May 01, 2009; ... ATLANTA -- FDA has accepted two proposals from Genentech for a Center for Drugs pilot to make it easier for biotech products to use Quality by Design for review, and the agency, along with its European counterparts, is trying to ease the path. In June 2008, CDER's Office of ...