Validation Times articles from September 2003

Validation Times archives from September 2003

FDA guidance emphasizes voluntary PAT deployment, but business, political climate may drive industry to move quicker.(Process analytical technology)
September 1, 2003... FDA's draft guidance on process analytical technology (PAT), released on Sept. 3, appears to deliver all the elements that the pharmaceutical industry asked for--namely, voluntary implementation that offers flexibility for companies adopting...

3 to 9 retests for OOS deemed acceptable to FDA, former CDER official says.(Out-of-spec results)
September 1, 2003... Although neither he nor FDA would give a ballpark figure on how many retests are "acceptable" for out-of-specification (OOS) test results with human drugs, the former Center for Drugs official who wrote the agency's guidance on OOS told an...

FDA may rewrite Part 11, but issues final guidance exempting 'legacy computers,' clarifies audit trails.(Electronic records)(Food and Drug Administration)
September 1, 2003... FDA Sept. 3 issued a final guidance on how agency-regulated companies and sponsors should adhere to the 1997 electronic records/signature rule (21 CFR Part 11), but the guidance is only the beginning of an effort to rewrite the controversial...

Industry more pleased with newest draft, concerned about conflicts with EU/ISO document.(Aseptic processing)
September 1, 2003... FDA's aseptic processing draft guidance, released Sept. 3, will be most beneficial to companies with enhanced technological innovations, according to FDA's Richard Friedman, chair of CDER's Aseptic Processing Guideline Revision Workgroup and a...

Comparability protocols may reduce application submission and filing requirements.(CMC)
September 1, 2003... FDA's draft guidance, "Comparability Protocols--Protein Drug Products and Biological Product, Chemistry, Manufacturing, and Controls Information," released Sept. 3, describes recommendations for implementing post-approval manufacturing changes...

FDA, EU expecting manufacturers to use CAPA to halt OOS, determine 'root cause'.(CAPAs)(United States. Food and Drug Administration)(corrective and preventive action)
September 1, 2003... Manufacturers should start deploying better corrective and preventive action (CAPA) procedures to thwart out-of-specification test results, and avoid citations for such on 483s, representatives from FDA, the European Union and industry told the...

AccuMed gets clean bill of health.(Human Drugs)(CIGNA Insurance Company of Texas. accuMed)
September 1, 2003... A 2002 FDA audit of AccuMed's Lawrenceville, NJ, plant revealed that GMP faults from the previous year had been adequately rectified, according to documents from the inspection, which was conducted by investigators Marea Harmon and Margaret...

Airgas Norpac passes unannounced follow-up audit with flying colors.(Human Drugs)
September 1, 2003... Airgas Norpac, Tacoma, WA, managed to escape a 483 when Seattle District investigator Connie Rezendes paid the company a surprise visit. The current inspection covered all aspects of the compressed medical oxygen filling operation,...

Edge Biologicals hit with numerous GMP, QS deficiencies.(Medical Devices)
September 1, 2003... Edge Biologicals, Memphis, TN, received a 483 following a 2002 inspection that served as a follow up to an inspection in which the maker of in vitro diagnostics got a warning letter in June 2001. However, in the latest audit, Edge was cited...

IVF device maker handed hefty 28-item 483.(Medical Devices)(in-vitro fertilization)(Mid-Atlantic Diagnostics)
September 1, 2003... New Jersey District FDA investigators Karen Tomaziefski and Loretta Nemchik's visit to the in-vitro fertilization (IVF) device manufacturer, Mid-Atlantic Diagnostics, Medford, NJ, revealed numerous deviations ranging from failure to establish...

FDA cites PPD Development with inadequate assay validation.(Blood/Biologics)(United States. Food and Drug Administration)
September 1, 2003... Bioanalytical laboratory PPD Development, Richmond, VA, received a seven-item 483 for inadequate validation of assays, failure to demonstrate stability, documentation issues and an inadequate recovery experiment, after a visit from...

Device company addresses quality, validation issues.(Medical Devices)
September 1, 2003... During an inspection of Wright Medical Technology, Arlington, TN, on April 28 through May 7, unnamed FDA investigators determined that the manufacturer's Transcend Hip System was being manufactured and distributed without completing all the...

Ludwig fails to validate processes for gamma irradiation of products.(Ludwig Medical)
September 1, 2003... FDA Investigator James Finn, during a May 19 to May 21 inspection at Ludwig Medical, Effingham, IL, determined that the manufacturer's specimen traps, labeled as sterile, did not conform to quality system regulations. Specifically, the Aug. 13...

Cardio Design lacks validation of the design controls for anal sensor, vaginal sensor.
September 1, 2003... During a March 10-11 inspection of Cardio Design, Castle Hill, NSW, Australia, FDA determined that the company had failed to maintain procedures for documentation and validation of the design controls for its products--Peritron Model 9300A with...

Electrode cable manufacturer fails to establish adequate QA/QC measures, FDA says.
September 1, 2003... An inspection of ElectraMold, Louisville, KY, a lead wire (electrode cable) manufacturing firm, on June 17 and 18, revealed the company failed to establish adequate management control to ensure that an effective quality system had been...

FDA says Astro insufficiently addressed QS regulation deviations.
September 1, 2003... An inspection on July 21-28 of Astro Instrumentation LLC, Strongsville, OH, which manufactures chemistry analyzers and is designing a renal dialysis filter reprocessing system, revealed numerous Quality System (QS) regulation deviations. ...

CardioCommand hit with validation, verification deviations.
September 1, 2003... Investigator Kevin Vogel inspected CardioCommand, Tampa, FL, on March 5-10, and found that it failed to establish procedures for, and conduct, quality audits. The investigator found quality system violations, including but not limited to MDR...