Validation Times articles from October 2003

Validation Times archives from October 2003

Industry, distributors, pharmacists disagree over level of GMPs, packaging to thwart counterfeiting.(Packaging/counterfeiting)
October 1, 2003... BETHESDA, MD -- At an Oct. 15 hearing here, drug industry representatives expressed support for FDA's move toward radiofrequency identification (RF id) on drug packaging, which offers an electronic pedigree and higher track-and-trace technology...

"Critical" data key to determining risk-based Part 11 compliance plan: FDA.(Electronic records/SOPs)
October 1, 2003... BALTIMORE -- Manufacturers confounded on how much they must adhere to FDA's electronic signature/records rule in the aftermath of new guidance issued Sept. 3 should ask themselves how "critical" the record is in terms of GMP compliance and...

Abbott using PAT to monitor batch records, raw materials.(Process analytical technology)
October 1, 2003... PHILADELPHIA -- As a way to maximize the benefits of process analytical technology (PAT), Abbott Laboratories is assimilating years of electronic batch information into an "assimilated batch" system, which is designed to organize the records to...

Challenge may be to R&D staff, not just QA/QC, says Mallinckrodt exec.(PAT)
October 1, 2003... PHILADELPHIA -- FDA has been trying to get the pharmaceutical industry to implement PAT as a means of applying real-time QA/QC instead of testing and validating batches after the fact, but the real challenge to PAT acceptance might not just be...

FDA not eyeing third party audits of raw materials; stressing C of As.(Excipients)
October 1, 2003... ALEXANDRIA, VA -- When it comes to excipients and their purity and veracity, particularly in light of counterfeiting and resulting public health problems, FDA is not going to require certification from third parties, but would not discourage...

Pfizer revalidates systems to become compliant following 70-item 483 for Pharmacia Sweden facility.(Human drugs)
October 1, 2003... Pfizer last year revalidated its computers and "instituted. a corporate-wide program to upgrade aseptic manufacturing operations in all our plants" following a blistering 2000 inspection of then-Pharmacia facilities in Sweden, which FDA audited...

Quintiles cited for validation, part 11 deficiencies.(Human drugs)
October 1, 2003... Quintiles' contract testing facility in Kansas City, MO, received a three-item 483 last year for deficiencies related to validation and control procedures, calibration and Part 11. A previous inspection in 2000 designated as a high priority...

Umbilical cord clamp manufacturer fails to implement corrective action.(Medical devices)
October 1, 2003... Alpha Industries, Clearwater, FL, received a 483 and warning letter this year after an FDA audit discovered numerous quality system deficiencies, including failure to initiate corrective and preventive action (CAPA) following a non-conforming...

Aventis cited for inadequate failure investigations, process deviations.(Blood & biologics)
October 1, 2003... Aventis Behring's Bradley, IL, plasma fractionator bioanalytical laboratory received a 13-item 483 for inadequate controls for deficiencies in investigating failures and process deviations. A previous inspection in April 2001, resulted in a...

Blood bank letter shows FDA still concerned about computer system access, passwords under Part 11.(Blood/Biologics)
October 1, 2003... A Sept. 25 warning letter to Community Blood Bank of Erie, Erie, PA, shows the agency will still cite Part 11-related problems in warning letters, although in this case, the Philadelphia District cited the "predicate rule"--drug GMPs--not Part...

HDC cited for inadequate CAPAs related to design controls, bioburden testing.(Medical Devices)
October 1, 2003... An April 14 to May 1 inspection led to a warning letter to HDC Corporation's, Milpitas, CA, V-Cath Peripherally Inserted Central Catheter (PICC) plant, primarily involving Quality System regulation violations, notably design verification and...

Life-Tech cited for sterilization validation, other GMP issues.(Medical Devices)
October 1, 2003... Life-Tech, Stafford, TX, a manufacturer of gastroenterological and urological devices, was cited for a variety of GMP/QS violations, including sterilizing a pump after a recall, but not validating whether its products could withstand...

Device reprocessor cited for failure to validate, clean, disinfect.(Medical Devices)
October 1, 2003... Bowie Memorial Hospital, Bowie, TX, which reprocesses surgical scissors, forcepts and hemostates, among other devices, was cited in an Aug. 27 warning letter for failure to validate its reprocessing, including steam sterilization, packaging and...

Hospital bed manufacturer's electric beds not in conformance, repeat violations.(Medical Devices)
October 1, 2003... An inspection of Vail Products, Toledo, OH, a hospital bed manufacturer, on June 16-19 revealed that its electric beds were not in conformance with Quality System requirements. The Sept. 8 warning letter emphasized that most of the deviations...