Validation Times articles from May 2002

Validation Times archives from May 2002

Committee works to create PAT guidance; FDA, industry reps say long-term benefits outweigh potential implementation problems.(Brief Article)
May 1, 2002... ROCKVILLE, MD -- Companies dragging their feet on adopting process analytical technology (PAT) might have to pick up the pace if they don't want to be left in the dust. That prediction was made by industry and FDA representatives at a May 8...

PAT benefits espoused by committee members.(Brief Article)
May 1, 2002... Although PAT implementation is totally voluntary, the general tone of FDA's May 8 meeting on the matter was that companies that do not embrace the technology will be left behind by the advances in manufacturing capabilities, which PAT will...

Part 11 deems sample request signatures as records; systems not Part 11-exempt.(Brief Article)
May 1, 2002... If a licensed health care professional signs a hand-held electronic device in order to receive samples from a pharmaceutical firm, FDA's electronic signature/records regulations (21 CFR Part 11) will treat this as a record, not an E-signature,...

IT urged to be involved in validation efforts, documentation tops 483 cites.(Brief Article)
May 1, 2002... FDA's Part 11 creator and chief enforcer, Paul Motise, has said there is a "disconnect syndrome" at agency-regulated establishments regarding the lack of involvement in software/computer system choosing, auditing and validation planning. ...

Preventive maintenance, dual files on equipment recommended.(Brief Article)
May 1, 2002... PHILADELPHIA - "There is a tendency on the part of nature to proceed toward a state of greater disorder," according to Mark Zemansky, author of "Heat and Thermodynamics." But the words recounted by Philadelphia-based pharmaceutical...

2-2-0 updates FDA monthly on validation corrections.(Brief Article)
May 1, 2002... OTC drug and cosmetics manufacturer 2-2-0 hopes to have completed work on correcting process validation deficiencies by the end of July, according to a company response to FDA following a Dec. 27 warning letter. Los Angeles district...

Pfizer spring cleaning of environmental monitoring extends to summer.(Brief Article)
May 1, 2002... Pfizer has promised FDA it will address all deviations by August, regarding a 483 with 31 GMP deviations, including environmental monitoring, which the agency issued after a November/December 2001 inspection of Pfizer's Terre Haute, IN,...

Dust clouds Bioster's contract cervical dilator sterility validation.(Brief Article)
May 1, 2002... An Aug. 29, 2001, inspection of Bioster, S.A. revealed the contract sterilization and control testing lab had "extreme levels of dust...observed in the exhaust fans" of its testing facilities, triggering a Nov. 16 warning letter (11159W). ...

Medtronic Midas Rex drill motor tests may have allowed overheating; test acceptance validation cited.(Brief Article)
May 1, 2002... FDA's inspection of Medtronic Midas Rex of Ft. Worth, TX, disclosed a number of problems in connection with the Midas Rex line of surgical drills, which suffered from overheating and led to a number of complaints in 1999 and 2000. The...

Warning letter release slowed by FDA chief counsel review.(Brief Article)
May 1, 2002... FDA has released few warning letters to industry and the public since a new procedure was enacted in March, which requires all warning and "untitled" letters to be cleared by the Office of the Chief Counsel. The policy covers warning and...

Unvalidated rework procedure one cause of metal shavings in tablets: FDA.(Brief Article)
May 1, 2002... A failure to validate rework procedures to yield product "meeting predetermined specifications" was one of the factors contributing to the presence of metal shavings in tablets manufactured by Berlex Laboratories, FDA said in a March 11 warning...

Biozone to have new stability testing within 60 days.(Brief Article)
May 1, 2002... Contract manufacturer Biozone Laboratories managed to sufficiently address a number of GMP violations resulting from a Feb. 11-20 inspection of the firm's Pittsburg, CA, facility but fell short of addressing stability issues which netted the...

West Agro assay methods do not conform to USP specs.(Brief Article)
May 1, 2002... A Feb 12-15, 20 and 25 inspection of iodide manufacturer West Agro revealed the firm's laboratory control sheets listed multiple assay methods without noting the actual method used for the specific analysis, inadequately validated assay methods...