Validation Times articles from February 2009

Validation Times archives from February 2009

Few in industry filing applications with nanotech materials, though FDAers ponder if better 'in-spec' products could be made.(CMC)
February 1, 2009... WASHINGTON -- Despite concerns out the risks of nanotechnology by consumer and environmental groups--and, p erhaps, some in Congress and the Obama administration--industry has not flooded FDA with applications for new drugs, devices and...

PAT principles, analytics, take lead role in QbD.(QbD)
February 1, 2009... Seven years after FDA launched its Pharmaceutical Quality for the 21st Century initiative, the agency continues to roll out specific plans for implementation. In September 2004, they published regulations on pharmaceutical manufacturing and the...

PQLI takes ICH principles to the next level.(PQLI)
February 1, 2009... BALTIMORE, MD -- In June 2007, the International Society for Pharmaceutical Engineering launched the Product Quality Lifecycle Implementation (PQLI) initiative. The five-year project was designed with pharmaceutical manufacturers in mind, and...

Smaller particles in largely unregulated cosmetics concern FDA for potential to leach under patient skin.(Nanotechnology)
February 1, 2009... WASHINGTON -- As industry considers using nanoparticles for drugs, devices and even packaging, FDA is concerned that smaller particles, if not made under proper GMP conditions and with some agency review, could deem them new drugs, and that...

FDA issues 26-item 483 to Amerifit Pharma.(Human Drugs)
February 1, 2009... An inspection of Amerifit Pharma's drug manufacturing facility conducted April 10-May 10, 2007, revealed numerous GMP violations. FDA investigator Debra Emerson issued a 26-item 483, noting the Woburn, MA, firm could not provide original...

Amneal Pharmaceuticals overlooks failed batches.(Human Drugs)
February 1, 2009... Amneal Pharmaceuticals did not sufficiently investigate the failure of product batches to meet specifications, wrote FDA investigator Douglas Kovacs during a July 5-17, 2007, inspection of the Paterson, NJ, facility. Specifically, two...

Poor testing and cleaning processes result in warning letter for Ben Venue Labs.(Human Drugs)
February 1, 2009... Several operations-related GMP violations were noted by FDA investigators Mark Parmon and Stephen Kilker as they inspected Bedford, OH, Ben Venue Laboratories May 7-June 15, 2007. The inspectors found that several lots of product had not...

CAPA deviations and flawed design controls at National Biological.(Medical Devices)
February 1, 2009... Following a Jan. 14-Feb. 27, 2008 inspection, device manufacturer National Biological Corp., based in Beachwood, OH, was cited for problems with its corrective and preventive action (CAPA) and design control processes. Investigator Laureen...

Sage Products lacks product quality and safety assurance.(Human & Animal Drugs)
February 1, 2009... Jan. 22--Chicago District Following a June 2-July 10 inspection of healthcare manufacturing company Sage Products, FDA warned that due to "the significant and recurring GMP observations documented during the current inspection, we are...

Multiple GMP violations noted at Virbac, Inc.(Human & Animal Drugs)
February 1, 2009... Dec. 10--Dallas District During a July 21-29 inspection, FDA investigators "documented numerous violations" of GMPs that caused Virbac's veterinary drug products to be deemed adulterated. Virbac's Quality Assurance was not made aware...

Device manufacturer cited for poor practices.(Medical Devices)
February 1, 2009... Jan. 6--Cincinnati District Maumee, OH, company Hammill Manufacturing, a medical implant manufacturer of prosthetics such as tibias, hips, shoulders, bone screws and spinal systems, as well as surgical instruments, has not consistently...