Validation Times articles from February 2002

Validation Times archives from February 2002

With sunsetting of 209 standard, question is if FDA will accept ISO 14644.(Brief Article)
February 1, 2002... The U.S. General Services Administration (GSA) Nov. 29 formally retired Federal Standard 209, which governed cleanrooms and their classification, as the U.S. officially recognized International Standards Organization (ISO) 14644-1-2 for all...

Ex-FDA lab director sees no specificity on retests in final OOS guidance.(William Ment, out-of-specification)(Brief Article)
February 1, 2002... If FDA ever gets around to issuing a final guidance on handling out-of-specification (OOS) results - a draft was issued in 1998 - industry should not expect the agency to provide specifics on the number of retests labs can do, says a former...

Phased compliance plan may pass FDA muster, consultant says.(Brief Article)
February 1, 2002... Phasing in compliance with FDA's electronic signature/records regulations (21 CFR Part 11) could be a practical approach to saving money and avoiding 483 and warning letter citations. Companies should start with their inventories first. ...

Overuse of resins in chromatography column cleaning, reliance on impurities tests not always advised.(by the Center for Biologics)(Brief Article)
February 1, 2002... SAN DIEGO - Manufacturers of biotech products regulated by the Center for Biologics should be wary of overusing resins in column chromatography cleaning and over reliance on impurities tests in lieu of determining what the impurities do to the...

Waterfall, lifecycle models need to be tweaked for Part 11, software, computer validation.
February 1, 2002... TAMPA BAY - The highly touted "Waterfall Model" and "Life Cycle Model" for doing change control should really be revised for purposes of computer/software change control, an ISPE workshop learned Feb. 12. John Hannon, Computer Systems...

FDA amends contract stability requirements on the fly for Celsis.(Celsis Laboratory Group)(Brief Article)
February 1, 2002... The contract stability industry picked up a brand new appreciation for its regulatory burden after the agency's 2000 inspection of Celsis Laboratory Group of St. Louis, MO, during which the agency made known its expectations regarding the...

Employee terminated after systemic data security/ Part 11 issues arise.(at DSM Catalytica Pharmaceuticals)(Brief Article)
February 1, 2002... Allegations of data falsification by an employee of contract drug maker DSM Catalytica Pharmaceuticals of Greenville, NC, served as the backdrop of a December 2000 audit by investigators Vicky Stoakes and Penny McCarver of the Atlanta district,...

Hands-on work lacks validation for Italian firm.(Brief Article)
February 1, 2002... Italy's Diffuplast, a manufacturer of enteral and parenteral nutrition bags opened its doors to investigator Ronald Weber on behalf of the Center for Devices and ended up with a five-item 483 with hits for design controls and sterilization...

BioPort gets FDA okay to sell anthrax vaccine in new facility after media fills are validated.(Brief Article)
February 1, 2002... BioPort of Lansing, MI, has drawn its fair share of ink the past few years, but its fortunes seem on the upswing lately despite a seven-item 483 in the latest inspection. In contrast, the previous audit in 2000 generated 17 deviations ...

Lab cited for serious validation, cleaning concerns.(2-2-0 Labs )(Brief Article)
February 1, 2002... The Dec. 27, 2001, warning letter to 2-2-0 Labs of Riverside, CA, included 11 hits for GMP deviations, including a citation for release of an unspecified number of lots of unnamed products containing methoxycinnamate that failed specifications....

Inspector concerned by foreign substances on production materials.(at Bachem California)(Brief Article)
February 1, 2002... Bachem California, Torrance, CA, took in a Jan. 14 warning letter, which led with a citation for lack of documentation that cleaning procedures were validated other than for unspecified glassware. The agency added that the lapse included...

Firm cited for averaging OOS outcomes in new drug testing.(Baxter Healthcare Corp., out-of-specification)(Brief Article)
February 1, 2002... Baxter Healthcare showed up on FDA's radar screen after an Aug. 7-17, 2001, audit of the Round Lake, IL, plant disclosed averaging of OOS outcomes for stability tests involved in amended new drug and new drug applications. In two...

483 is a laundry list of validation, documentation problems.(at Cardinal Enterprises)(Brief Article)
February 1, 2002... Investigator Daryl Dewoskin of the New England district combed through the Middletown, RI, plant run by Cardinal Enterprises in October and November 2001 and the resulting Dec. 7 warning letter included a citation for validation documents that...

FDA snares 3 more OTC drug makers for GMP problems.(Opti-Med Controlled Release Labs)(Imperial Drug & Spice)(Wayzata Bay Products)
February 1, 2002... Detroit District director Joann Givens went into no detail in her Jan. 9 warning letter to Opti-Med Controlled Release Labs of Seymour, IN, which included a citation for failure to "make an appropriate laboratory determination of satisfactory...

Warning letter for device manufacturer cites design control SOP.(Sonora Medical Systems )(Brief Article)
February 1, 2002... Investigator Nicholas Nance of the Denver District Office handled the October 2001 inspection of Sonora Medical Systems of Longmont, CO, a subsidiary of Misonix, Farmingdale, NY, and generated a 483 leading to a Dec. 20, 2001, warning letter...

Cush hires consultant in wake of warning letter.(Brief Article)
February 1, 2002... Cush Industries of Piney Flats, TN, took in a Jan. 24 warning letter that did little other than briefly list the findings. FDA wrote that the deviations included "inadequate and incomplete validation of device sterilization cycle,...