Validation Times articles from June 2003

Validation Times archives from June 2003

Food and Drug Administration to issue final Part 11 guidance later this summer; pre-'97 legacy systems, e-signatures need to comply.
June 1, 2003... CHICAGO -- FDA is planning this summer to release final guidance for the agency's electronic/signature records regulation (21 CFR Part 11), and industry comments to date on the February draft generally favor the agency's new risk-based...

Food and Drug Administration may re-issue some revoked Part 11 guidance; validation guide still has merit.
June 1, 2003... With FDA poised to issue a final guidance next month on its electronic signature records rule (21 CFR Part 11), some experts say it is possible the agency might actually bring back some of the guidance documents it revoked in February. ...

Key CDER [Center for Drug Evaluation and Research] staffer defends need for master plans and documentation, says validation is lifecycle activity.
June 1, 2003... ARLINGTON, VA -- Validation master plans and documentation will still be critical components of GMP compliance and firms ought to start viewing process validation not just as a step in the manufacturing process, but an ongoing activity from...

Novartis using PAT with aid of IVIVC; exec. sees continued three-batch validation.(Process analytical technology with the aid of in vivo/in vitro correlation.)
June 1, 2003... ARLINGTON, VA -- Novartis already has implemented process analytical technology (PAT) in some facets of its manufacturing, aided partly through in vivo/in vitro correlation (IVIVC), but a company executive sees traditional three-batch...

PAT beneficial to biologics, and biotech, but new GMP rules not needed, Zoon says.(Process analytical technology.)(Interview)
June 1, 2003... RESTON, VA -- Former Center for Biologics Director Kathryn Zoon, Ph.D., who left FDA in December after a decade in that post, said process analytical technology (PAT) has applicability to biotech drugs and other biologics, but there is no need...

Computer validation cannot be 100% verified or validated FDAer says.
June 1, 2003... The "gray zone" stands between FDA regulations and industry standards best practices. In order to discuss computer validation in the gray zone, regulatory authority needs to be connected to the design authority. John Murray, software and Part...

'Risk-based' approach urged as firms lack enough QA/QC staff.
June 1, 2003... PHILADELPHIA -- FDA complains about insufficient resources, but so should drug and device QA/QC departments, so says Barbara Immel, principal of Immel Resources, based in Petaluma, CA. Immel told a May 20 Center for Pharmaceutical...

Baxter Healthcare Corp. racks up 483 for numerous stability problems and OOS deficiencies.
June 1, 2003... Chicago District investigator Susan Bruederle uncovered a gamut of deficiencies ranging from stability and out of specifications (OOS) problems at Baxter's Round Lake, IL control testing laboratory, for which she issued the company an...

Piedmont cited for validation faults in water system.
June 1, 2003... Investigators Penny McCarver and Jawaid Hamid from FDA's Atlanta District hit contract manufacturer of medicated shampoos and topical pain relief sprays Piedmont Laboratories, Gainesville, GA, with a 12-item 483 following a 2001 audit. ...

Celltech receives third clean audit following numerous problems under Medeva.
June 1, 2003... Celltech Pharmaceuticalsappears to have turned around problems associated with microbial contaminations discovered in 1999 when the company was known as Medeva Pharmaceuticals, according to records from a 2002 FDA inspection, which resulted in...

Recurring Part 11 problems plague Hill-Rom Netlinx.
June 1, 2003... A follow-up inspection by Atlanta District's investigators Claudette Brooks and Harold Blackwood, found that documentation of the software validation of the Hill-Rom Netlinx's WatchChild (baseline) program was not complete and thus the duo...

No quality policies in place for Southwest Instrument's penile prosthesis instruments.(Brief Article)
June 1, 2003... An FDA inspection of Southwest Instrument Company's operations at Wilson Urology Associates, Van Buren, AR, revealed that the company's surgical instruments intended for use during penile prosthesis implant surgeries were not in conformance...

ConMed cited for OOS, software validation.
June 1, 2003... ConMed, of Utica, NY, received a warning letter May 8 in part for OOS issues and software validation following an audit of its Centennial, CO, plant by FDA and the Colorado Department of Public Health and Environment, Environmental Protection....

Validation, inspection non-conformities slam wheelchair manufacturer.
June 1, 2003... Failure to validate computer software for its intended use and failure to establish and maintain adequate procedures for verifying device design landed Merits Health Products, Taiwan, a warning letter, which was dated Feb. 4, but just recently...

Previous 483 inspection observations not addressed, no quality audits since 2001.(Brief Article)
June 1, 2003... FDA hit Montco Precision Machines with failure address significant GMP violations as cited in a 483 from a previous inspection concluded on June 29, 2001. The May 12 letter stated that the Tomball, TX-based company still had not documented...

FDA hits ventilatory recorder manufacturer with failure to establish design control procedures.(Medical devices)
June 1, 2003... The lack of procedures to establish and maintain adequate control of the design of its medical device--the SnoreSat.Rernmcr Recorder--netted SagaTech Electronics a warning letter, which was dated April 7. During an inspection of the...

Catheter manufacturer fails to address design change, labeling violations.(Medical devices)
June 1, 2003... The April 21 warning letter referred back to a Jan. 28-Feb. 5, 2003 inspection of Tyco International's Tyco Healthcare/Kendall Division, Argyle, NY, which landed the company, headquartered in Portsmouth, NH, a 483. The letter referred...