Validation Times articles from February 2007

Validation Times archives from February 2007

PAT is 'emblematic' of new pharmaceutical thinking under 'Critical Path,' Woodcock tells IFPAC.(PAT)
February 1, 2007... BALTIMORE -- Process analytical technology (PAT) is an important element of FDA's "Critical Path Initiative," though the initiative has largely gotten public attention due to its emphasis on clinical and preclinical issues, FDA's deputy...

New Volume 9A reporting rules allow EU members to audit adverse events.(Inspections)
February 1, 2007... The European Commission has released Volume 9A of "The Rules Governing Medicinal Products in the European Union," a detailed guidance document concerning pharmacovigilance of human drugs in the European Union, and allows member states to...

Validating consumer COTS lab instruments results in cost and time savings, better than GAMP: Amgen.(Software validation)
February 1, 2007... ARLINGTON, VA -- Validating consumer-off-the-shelf (COTS) laboratory instruments is beneficial over Good Automated Manufacturing Practice (GAMP)-influenced processes because vendor qualification documents are leveraged, and can result in 40%...

Documentation, knowing what you want to achieve key in validating hardware.(Computer validation)
February 1, 2007... ARLINGTON, VA -- Computer validation is "an ongoing process of establishing documented evidence which provides a high degree of assurance--as determined by somebody qualified to make that decision--that a computerized system will consistently...

PAT used at Pfizer to improve product knowledge, remove variability from process.(PAT)
February 1, 2007... BALTIMORE -- PAT is used online or at-line at Pfizer Global Manufacturing "to obtain improved process knowledge, to identify and remove sources of variability and, thereby, achieve reliable product performance and quality," a senior Pfizer...

Change control and calibration net 4-item 483 for Chemtura.(Human drugs)
February 1, 2007... API [active pharmaceutical ingredient] manufacturer Chemtura Corporation, Memphis, TN, was the recipient of a four-item 483 in a 2006 GMP inspection for inadequate change control procedures, and calibration not being conducted annually....

Part 11 rears its head in Draxis Pharma 3-item 483.(Human drugs)
February 1, 2007... A quality, production, laboratory and packaging systems inspection of Draxis Pharma, Kirkland, Quebec, Canada, showed that FDA still intends to cite firms for failure to comply with 21 CFR Part 11 for computer systems and electronic records,...

Nine-item 483 for Positron for calibration and quality audit problems.(Medical devices)
February 1, 2007... Positron Corporation, Houston, TX, was written up in a nine-item 483 for failing to keep proper calibration documentation and failing to conduct quality audits. Also issued was an April 26, 2004, warning letter. The report was prepared by...

CAPAs and quality audits cited for Talon Acrylics in 3-item 483.(Medical devices)
February 1, 2007... Talon Acrylics, Portland, OR, a manufacturer of liquid thermoplastic products for the dental industry, received a three-item 483 for failure to establish and maintain procedures for implementing CAPAs and failure to maintain quality system...

Bell-More warned for control system failures.(Human drugs)
February 1, 2007... An Aug. 7-17, 2006, GMP inspection of drug testing lab Bell-More Laboratories, Hampstead, MD, found what FDA stated to be "severe" violations of GMP regulations. The firm lacked an adequate assessment of the cross-contamination risks posed...

Omnicare/Heartland cited for "serious" violations in quality control systems.(Human drugs)
February 1, 2007... An inspection of an Omnicare/Heartland Repack Services LLC, a drug repackaging facility in Toledo, OH, conducted June 27-Aug. 11, 2006, revealed numerous GMP violations in the area of quality control systems that FDA termed as "serious." It...

DreamWest receives warning letter for failure to validate manufacturing processes.(Medical devices)
February 1, 2007... DreamWest Innovations, San Antonio, TX, was inspected Nov. 1-9, 2006, and FDA found that the specification developer and manufacturer of the SwiftGrip Rapid Intubation Kit, was not in full compliance with the GMP/Quality System regulation. ...

Encore Medical slapped with warning for CAPAs, spec change procedures.(Medical devices)
February 1, 2007... FDA stated that an inspection of Encore Medical--a manufacturer of orthopedic products for reconstructive surgery of hips, knees, shoulders, and spines based in Austin, TX--found GMP violations that included but were not limited to the...

CAPAs and validation flaws trip up Levitronix.(Medical devices)
February 1, 2007... A Sept. 26-29, 2006, inspection of Levitronix, Waltham, MA, determined that the manufacturer of the Levitronix CentriMag Extracorporeal Blood Pumping System and the Levitronix CentriMag Back-Up Console was in violation of GMPs in the following...