Validation Times articles from July 2003

Validation Times archives from July 2003

FDA-CaSSS work group calls for initial test method performance capabilities--whether 'qualification' or not.(CMC)
July 1, 2003... GAITHERSBURG -- A joint FDA-industry working group July 24 agreed that biopharmaceutical companies should conduct some sort of initial test method performance capabilities--whether it was termed qualification or not--but could not come to a...

Despite exemption, really old records may need forensics expert to achieve compliance.(Legacy systems)
July 1, 2003... CHICAGO -- FDA regulations governing retention of electronic records (21 CFR Part 11) may cause difficulties for drug makers in the coming years, for as new computer platforms emerge, records created on older systems may no longer be clearly...

Individualized processes, not one-size-fits-all validation, seen necessary for burgeoning industry.(Cell therapy)
July 1, 2003... With about 350 INDs for cell therapy clinical trials, of which only about a quarter are industry-sponsored, traditional three-lot validation and other hallmarks of GMPs will not be valid, according to a discussion at the Biotechnology Industry...

Contract manufacturer develops facility with multiple cell-therapy drugs in mind.(Cell therapy)
July 1, 2003... Progenitor Cell Therapy has developed a multiple-product production facility, which is designed to prevent cross-contamination among products, but which also could be a model for individualized cell therapy drug production. Robert Preti,...

Elan cited for validation, part 11 issues.(Human drugs)
July 1, 2003... Atlanta District investigators Penny McCarver and Bonita Chester discovered validation and Part 11 problems at pharmaceutical manufacturer Elan Operations,' Gainsville, GA, plant. The duo also cited the firm because written procedures did not...

Pre-approval inspections uncover stability fluctuations.(Human drugs)
July 1, 2003... Injectable drugs manufacturer Gensia Sicor, Irvine, CA, narrowly escaped a 483 despite stability fluctuations discovered by investigators Terri Dodds and Kham Phommachanh of the Los Angeles District. The duo visited the facility to conduct...

Batch records and water problems plague H2O Plus.(Human drugs)
July 1, 2003... Investigator Jason Chancey of the Chicago District uncovered a gamut of problems, mostly associated with batch production records, cleaning procedures and, ironically, its water system for OTC drugs manufacturer H2O Plus's Chicago facility,...

French firm not aware of medical device reporting responsibilities.(Medical devices)
July 1, 2003... Device failures and the recall of eight batches of ceramic femoral heads for hip implants distributed in the U.S. and other countries prompted a baseline Quality Systems Inspection Technique (QSIT) audit, at France's Saint Gobain Ceramiques...

Numerous cleaning validation issues uncovered in Bayer biologics audit.(Blood & biologics)
July 1, 2003... A "Team Biologics" inspection of Bayer's Clayton, NC, facility uncovered a host of cleaning validation problems after FDA's Center for Biologics conducted a March 2001 investigation. In the resulting 26-item 483, 21 of the observations...

Umbilical cord clamp manufacturer fails to establish quality controls.(Medical devices)(Brief Article)
July 1, 2003... Alpha Industries, Clearwater, FL, failed to establish and maintain procedures for implementing CAPAs resulting from the receipt of a 483 involving an umbilical cord clamp, according to a just-released April 23 warning letter. The company...

IMS hit with validation, documentation non-conformities.(Medical devices)(Brief Article)
July 1, 2003... Failure to analyze sources of quality data to identify existing and potential causes of non-conforming product; and failure to document corrective and preventative actions including analysis of sources of quality data, investigations of causes...

EndoMed hit with no FDA-approved IDE, no PMA.(Medical devices)(Brief Article)
July 1, 2003... FDA investigators Sandra Shire and Charles Larson determined that EndoMed, Phoenix, distributed significant risk devices without an FDA approved IDE or pre-market approval application. Specifically, on Feb. 3-5, the investigators noted...

Hopkins hit with no SOPs, no validation, standardization policies.(Blood and biologics)(Brief Article)
July 1, 2003... Upon a May 30 inspection of Johns Hopkins Hospital and Health Care Systems' (Baltimore) blood bank facility--Feb. 3-6, 10 and 25--the agency found GMP deviations including failure to observe, standardize and calibrate equipment on a regularly...

Product manufacturer cited for no validated processes.(Cosmetics)(Brief Article)
July 1, 2003... Following an inspection, Nov. 26 through Dec. 3, 2002, FDA determined that CBC Research's (Sarasota, FL) over-the-counter (OTC) pharmaceutical and cosmetic skin care products' manufacturing facility failed to have adequate written procedures...