Validation Times articles from August 2003

Validation Times archives from August 2003

FDA not seen reinstating draft guidances revoked in February; progress report on GMP Initiative seen by early September.(Electronic records)
August 1, 2003... CHICAGO -- FDA's final guidance document on its electronic signature/records regulation (21 CFR Part 11) is likely not to bring any draft guidance revoked by the draft "risk-based" Part 11 guide, which was issued in February, officials said....

'Intended use' is validation, FDA meeting told; better acceptance methods seen as key.(Acceptance criteria)
August 1, 2003... GAITHERSBURG, MD -- The most common validation shortcomings in pharmaceutical firms are poorly written methods for acceptance criteria and overuse of "historical performance." Additionally, too much or too little validation. When acceptance...

Process validation tops warning letter citations in '02; fewer letters issued.(Compliance/Enforcement)
August 1, 2003... CHICAGO -- Process validation has replaced laboratory controls as the leading area of GMP violations noted on FDA warning letters to drug manufacturers, excluding violations at medical gas packing facilities. According to data from fiscal...

Comp. protocols seen taking on increasing importance in validation, GMP compliance.(Comparability)
August 1, 2003... PHILADELPHIA -- Product comparability, a cornerstone of FDA's GMP Initiative, will take on increased importance in validation and GMP compliance, even in the near term, industry executives said here July 22-23. "There's an increased...

FDA is becoming more proactive about telling firms 'what we expect,' ex-inspector says.(Cleaning validation)
August 1, 2003... PHILADELPHIA -- FDA is increasingly "getting more proactive about speaking their mind" on cleaning validation during inspections, in some cases saying: "This is what we expect," and not just let industry drive the standards. That's the...

Par hit with 18-item 483 for GMP, validation deficiencies.(Human drugs)
August 1, 2003... New York District investigators Matthew Spataro and Michael Levine found that generic pharmaceutical manufacturer Par Pharmaceuticals failed to qualify critical equipment and lacked developmental data for certain specifications. According...

Pre-approval GMP audit results in 14-item 483 for Part 11, validation.(Human drugs)
August 1, 2003... Ben Venue Labs small-volume parental plant in Bedford, OH, invalidated two sterility failure tests that had not been re-evaluated from a previous audit, and had violations of Part 11 and other GMP validation requirements, according to records...

Fractionator gets 25-item 483 for process validation, OOS, failure investigations.(Blood & Biologics)
August 1, 2003... Cangene ran into a host of problems, ranging from process and cleaning validation issues and adverse events reporting out-of-specification (OOS) results, and failure to follow SOPs, after FDA's Center for Biologics conducted a September 2000...

Correction.(Brief Article)(Correction Notice)
August 1, 2003... Correction: In our July issue (pages 9-10), we incorrectly listed the city in which medical device manufacturer, St. Gobain, is located as Cedex, France. The correct location is Eureux, France. Cedex refers to the postal code system.

Forest Labs fails to establish lab controls, lacks written production procedures.(Human drugs)
August 1, 2003... Forest Labs received an Aug. 7 warning letter citing GMP deviations at its Cincinnati, OH, plant regarding the manufacture of Levothroid (levothyroxine sodium tablets), Armour Thyroid (thyroid tablets) and process validation faults with...

PrePak cited for stability, packaging faults with repackaged drug products.(Human drugs)(Brief Article)
August 1, 2003... Unnamed investigators, inspecting PrePak Systems, Cookeville, TN, on April 15-21, cited the repacker for not bearing appropriate product expiration dates and ensure that its repackaged drug products met applicable standards of identity,...

Roche to address Disetronic's GMPs, including software validation.(Medical Devices)
August 1, 2003... Roche Diagnostics is seeking to bring Disetronic Medical Systems, AG, Burgdorf, Switzerland, into GMP compliance after the company--which Roche had just purchased--received a June 11 warning letter, primarily citing software validation and...

Image analysis fails to obtain approval.(Medical Devices)
August 1, 2003... A March 3-5 inspection revealed that Image Analysis, Columbia, KY, made multiple revisions to the software packages that were part of its QCT Bone Mineral Analysis Systems, including approximately 29 changes to the QCT-3000 software and...

Mercy Blood Bank cited for software validation, error reporting.(Blood/biologics)
August 1, 2003... Failure of staff at Baltimore, MD-based Mercy Medical Center's unlicensed blood bank to sign off on computer system validation contributed to receipt of a warning letter dated July 25. An FDA audit April 15-17, 21-22 and 28 revealed the...

Blood and tissue center lacks quality, maintenance controls.(Blood/biologics)
August 1, 2003... Unnamed inspectors visited South Texas Blood and Tissue Center, San Antonio, from Feb. 24 through March 18, and noted serious violations of quality assurance and oversight functions, including the center's computers. According to a July 17...

LifeSouth fails to file BPD reports.(Blood/biologics)(Brief Article)
August 1, 2003... FDA conducted an inspection of LifeSouth Community Blood Centers' facility in Montgomery, AL, on March 12-21, and April 2-7, and found that the facility had not filed Biological Product Deviation reports on three units that represented a...