Validation Times articles from February 2004

Validation Times archives from February 2004

FDA still has no internal agreement on validating assays, revising process guide of '87.(Assay validation)
February 1, 2004... SAN DIEGO -- FDA staff are still trying to come to consensus on how to define test method qualification and validation, despite a new "white paper" created following last month's California Separation Science Society (CASSS) meeting in...

Drug, vaccine, biologic firms have two years to provide new bar coding on labels; medical devices, bulk drugs seen next.(Packaging)
February 1, 2004... WASHINGTON -- FDA Feb. 27 issued final regulations requiring bar codes on drugs and biologics, including vaccines, which will require industry within two years--but only 60 days after approval of new drugs and biologics--to provide linear bar...

Amgen's risk model for small-scale process characterization produces bigger yields.(Risk analysis)
February 1, 2004... ARLINGTON, VA -- Process characterization of biopharmaceutical processes on a small scale can improve success rates in manufacturing and even reduce the number of process-related incidents to improve the process-related incidents to improve the...

RF ID seen offering cutting edge tools for industry, despite not being required by FDA.(Cold chain distribution)
February 1, 2004... PHILADELPHIA -- Although FDA is not requiring RF ID technology in its final bar coding rules, RF ID may have a significant, positive outcome on best practices for cold chain distribution, according to speakers at an International Quality and...

New guidelines for cold chain distribution evolving.
February 1, 2004... PHILADELPHIA -- There are no national or international regulations guiding cold chain distribution, but a few industry groups are trying to change that. The Pharmaceutical Cold Chain Discussion Group was started by the Parenteral Drug...

Validation deficiencies and OOS results land Hi-Tech 483.(Human drugs)
February 1, 2004... Several validation deficiencies and out-of-specification (OOS) results were discovered when Lawrence Farina of FDA's New York District conducted an active pharmaceutical ingredient (API) survey of Hi-Tech Pharmacal. The audit requested...

Wyeth receives 483 for validation, calibration deficiencies.(Human drugs)
February 1, 2004... Several GMP deficiencies, including invalidation of atypical data results, instrument calibration and failure to follow written procedures were uncovered at Wyeth's Puerto Rico plant, which manufactures prescription and OTC drugs. FDA's Jorge...

Validation deficiencies, inadequate sterility tests plague CryoLife.(Blood & Biologics)
February 1, 2004... Human tissue processor and device manufacturer CryoLife was slammed with a 12-item 483 for inadequate validation, invalid sampling plans, inadequate validation documentation, failure to follow written procedures and failure to follow procedures...

Agency says Kos repeated Quality Control violations.(Human drugs/Biologics)
February 1, 2004... Failure of Kos Pharmaceuticals to correct problems FDA found in a 2002 audit of its Edison, NJ, plant landed the firm a warning letter, which dealt mostly with dissolution and content uniformity problems plus a failure to handle drug quality...

CBER says firm's activator kit exceeds scope of the pharmacy practice.(Human drugs/Biologics)
February 1, 2004... Custom Compounding Centers, Little Rock, AR, got a Dec. 23 warning letter from the Center for Biologics after the agency determined Custom's compounding of "activator kits" containing an unidentified product regulated as a biologic, believed to...

Hospital transfusion service violates GMP regulations for blood components.(Human drugs/Biologics)
February 1, 2004... An inspection of the Rusk County Memorial Hospital & Nursing Home's, Ladysmith, WI, transfusion service on Aug. 7-8, 2003, revealed violations of GMP regulations for blood and blood components. Specifically, the Dec. 23, 2003, warning...

Ambco lacks control procedures, fails at process validation activities.(Medical devices)
February 1, 2004... During an Oct. 4-10, 2003, inspection, FDA found that Ambco Electronics, Tustin, CA, was not conducting any process validation activities, and did not have methods established for addressing the identification, documentation, evaluation,...

DeRoyal hit with validation, stability violations.(Medical devices)
February 1, 2004... Although the products were medical devices, a recent inspection of DeRoyal Industries, Powell, TN, focused on drugs-oriented issues, such as the statistical validity of a sampling plan for the firm's production of powders and gels that are used...

Lumbar pain-treatment manufacturer violates GMP requirements.(Medical devices)
February 1, 2004... FDA found significant GMP inspectional observations at Lordex' plants in Houston and Brookshire, TX, according to a Dec. 29, 2003, warning letter. All of the violations found during the Oct. 15-Nov.15, 2003, audit related to the...

Agency questions Odyssey's quality system.(Medical devices)
February 1, 2004... Following an Oct. 20-24 inspection, FDA determined Odyssey Medical, Memphis, TN, to be in violation of Quality System rules; specifically, an inadequate quality control system, inadequate quality audits, inadequate training of firm personnel,...