Validation Times articles from May 2007

Validation Times archives from May 2007

Parametric Release CPG to be revised as sterile drug recalls are on the rise.(Aseptic processing)
May 1, 2007... BETHESDA, MD -- The Parametric Release Compliance Policy Guide is under revision by FDA, coming on the heels of an increase in product recalls due to a lack of sterility assurance. There were 25 such cases in FY '06, compared to 18 in FY '05...

New paradigm benefits include regulatory flexibility, fewer lot rejects, recalls: FDA's Cherney.(Quality-by-design)
May 1, 2007... BETHESDA, MD -- The potential benefits for transitioning to the new paradigm--meaning the "desired state" of drug manufacturing using quality-by-design (QbD) principles--are substantial: regulatory flexibility, smoother transitions from IND to...

Failure to qualify off-the-shelf disinfectants becomes leading 483 item.(Cleaning validation)
May 1, 2007... BETHESDA, MD -- Some of the more common 483 observations regarding cleaning procedures and disinfectants are "no data to support the appropriateness of the disinfectants used," "did not include efficacy studies for solutions currently used,"...

Corporate defendants can be held liable even if they did nothing, FDAer, other attorneys tell BIO.(Compliance programs)
May 1, 2007... BOSTON -- Employees of drug, device and biologics manufacturers can still be held liable in criminal and civil cases when their firms run afoul of the law, even if the individual defendants knew nothing of the infractions, a top FDA attorney...

Change within design space is not a regulatory change: Genentech official.(QbD)
May 1, 2007... BETHESDA, MD -- One of the key implications of ICH [International Conference on Harmonization] Q8 is that working within your design space is not considered a regulatory change. Only movement out of a design space is considered to be a change...

Boehringer Ingelheim has clean audit in validation activities.(Human drugs)
May 1, 2007... A GMP inspection of Boehringer Ingelheim Espana S.A., Barcelona, Spain, on quality, laboratory control and equipment resulted in no deficiencies being observed by investigator Vlada Matusovsky, who conducted the audit for FDA's Center for...

Cambrex slapped with 7-item 483 for admin assistant validating results in computer system.(Human drugs)
May 1, 2007... Cambrex Profarmaco Milano, Paullo, Italy, netted a seven-item 483 because an unqualified administrative assistant was assigned as the site director in a computer system to validate analytical results and modify release specifications. Only...

Contract sterilizer nets clean FDA inspection.(Medical devices)
May 1, 2007... Sterigenics US (formerly Ion Beam Applications), Corona, CA, did not receive any observations from FDA in a recent routine inspection focusing on CAPAs, production and process controls and quality and laboratory systems, conducted by...

Part 11 violations for computer validation flaws trip up organ center.(Biologics)
May 1, 2007... A recent audit netted a 483 for LifeGift Organ Donation Center, Houston, TX, including a citation for failure to validate its computer software performance in the area of donor referral operations, violates FDA's electronic records rules (21...

Iren cited for failure to verify identify drug product components.(Human drugs)
May 1, 2007... A GMP inspection of Iren Corporation, Union Dale, PA, a drug manufacturing facility, found significant deviations from GMP regulations, such as failure to verify the identity of each component of a drug product. Specifically, the April 3...

Medico Labs lacks system for reprocessing batches.(Human drugs)
May 1, 2007... Medico Labs, Hamilton, NJ, was found to be in violation of GMP regulations, including: Failure to establish and follow procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all...

Failure to validate trips up Clark Research.(Medical devices)
May 1, 2007... An audit of Clark Research and Development, Folsom, LA, netted an April 9 warning letter, in which FDA stated that the manufacturer of the Clark Biocompatible Hemoperfusion Cartridges was in violation of the FD&C Act. According to the...

Davol written up for "serious regulatory problems".(Medical devices)
May 1, 2007... Serious regulatory problems were noted in a recent audit of Davol, Granston, RI, the maker of the Composix Kugel Hernia Patches and Salute Fixation devices. For example, the April 24 warning letter stated that Davol failed to establish and...

Defibtech warned for design validation flaws.(Medical devices)
May 1, 2007... A March inspection of Defibtech, Guilford, CT noted that the maker of automated external defibrillators (AEDs) was out of conformance with the Quality System regulation. An example noted in the April 24 letter was failure of design...

Software validation flaws noted in LifeCare Tech warning letter.(Medical devices)
May 1, 2007... An FDA inspection of LifeCare Technologies, Tampa, FL, conducted Aug. 21-23, 2006 determined the following violations related to the firm's production of its Perinatal Information Network (P.I.N.) software: Failure to establish and...

Rhytec written up for design validation.(Medical devices)
May 1, 2007... A Dec. 13, 2006-Jan. 18, 2007, audit of Rhytec, Waltham, MA, the distributor of the Portrait Plasma Skin Resurfacing (PSR3) System, determined that the firm was in violation of GMP requirements, such as, failure to establish and maintain...

Sun Biomedical cited for validation and faulty processes.(Medical devices)
May 1, 2007... Sun Biomedical Laboratories, Blackwood, NJ, was cited for an assortment of validation problems related to drug screening tests, according to an April 12 warning letter, which was issued nearly a year after an April 3-10, 2006, FDA audit. ...

Blood bank fails to investigate adverse reactions.(Biologics)
May 1, 2007... Bothwell Regional Health Center, Sedalia, MO, was found to not be in conformance with GMP regulations, such as, failure to perform a complete investigation of each reported adverse reaction. For example, the April 16 warning letter noted...