Validation Times articles from January 2004

Validation Times archives from January 2004

FDA pondering PAT for biologics, but not Phase I drugs; '87 process validation guide may be redefined.(Process analytical technology)
January 1, 2004... WASHINGTON -- FDA officials told a biotech meeting in Washington Jan. 8 that they are considering broadening the scope of its Process Analytical Technology (PAT) Initiative to include biologics, since facets of PAT are more widely used in the...

FDA hammers out 'risk' definition; moves closer to developing analytical models.(Analytics/risk)
January 1, 2004... WASHINGTON -- FDA is leaning toward associating risk with clinical performance, whereby risk is defined as delivery and safety as described on the drug label, a top Center for Drugs compliance official said Jan. 6. "Risk is associated with...

Six-sigma strategy touted to manage PAT, but one expert is not sure.(Root cause analysis)
January 1, 2004... ARLINGTON, VA -- To move manufacturing science from its present state [not capable and unstable] to the desired state, John Walker, vice president, Engineering, TechniKrom, Evanston, IL, told IFPAC attendees Jan. 13 that "you can't improve what...

FDA shows shift from rigidity to flexibility with regulating PAT.(PAT)
January 1, 2004... WASHINGTON -- The pharmaceutical manufacturing industry should be able to achieve the "desired state," as laid out in FDA's PAT initiative, in the next decade, said Ajaz Hussain, Ph.D., deputy director of CDER's Office of Pharmaceutical...

Contract manufacturer says $1 million can be saved annually through online bioburden testing.(Bioburden)
January 1, 2004... WASHINGTON -- Contract manufacturer Xcellerex says companies can save $1 million a year in rejected or reworked products through a $3 million initial investment to do online bioburden QC testing for fillable drug products (not tablets or...

42-item 483 to Barr cites lab issues, SOPs, AE reporting.(Human drugs)
January 1, 2004... Barr Laboratories' Pomona, NY, facility received a 42-item 483 for deficiencies ranging from post-marketing adverse drug experience (PADE) reporting, failure to follow SOPs and inadequate testing and qualification. Conducting the 2002...

Unit Dose Packaging calls GMP rules 'draconian,' closes facility after FDA audit.(Human drugs)
January 1, 2004... Human drug and cosmetic manufacturer Unit-Dose Packaging, sold its assets following an unannounced GMP inspection conducted by Richmond Yip of FDA's Los Angeles District, who uncovered negligent quality GMP deficiencies, including no finished...

Anonymous complaint triggers inspection; 483 issued for different reasons.(Medical Devices)
January 1, 2004... Aurora Imaging Technology got a rare, unannounced inspection due to an anonymous complaint that the Andover, MA, firm was selling MRI equipment without a 510(k). Though this proved to be unfounded, Aurora still wound up with a 483 for...

Boehringer Ingelheim cited for inadequate CAPAs, validation deficiencies.(Blood & Biologics)
January 1, 2004... A "Team Biologics" inspection found biologic drug maker Boehringer Ingelheim Pharma KG, Biberach, Germany, to be deficient in its investigations and corrective actions and also uncovered inadequate validation, aseptic processing deviations, OOS...

Staar Surgical cited for failure to do root cause analysis, have validation SOPs.(Medical Devices)
January 1, 2004... Staar Surgical Co., Monrovia, CA, received a Dec. 22 warning letter for failure to perform root cause analysis of complaints that the agency said should have been filed as Medical Device Reports (MDRs), and not having proper SOPs regarding the...

IVD maker cited for not validating 'Excel'.(Medical Devices)
January 1, 2004... Eldon Biologicals A/S, a Danish in vitro diagnostics manufacturer, became the latest FDA-regulated company to get cited for failure to validate Microsoft Excel, along with getting hit for numerous validation deficiencies. The Dec. 23...

Agency bars IND Diagnostic products entering U.S.; validation a key concern.(Medical Devices)
January 1, 2004... Validation was the number one concern with IND Diagnostic, Delta, BC, Canada, which got a warning letter dated Dec. 23 following a June 2-5 inspection by an unnamed FDA investigator and Damian Kakwaya, Medical Device Specialist for Health...