Validation Times articles from July 2004

Validation Times archives from July 2004

International specifications for biotech impurities advocated; industry wants to see FDA 'expectations'.(Impurities)
July 1, 2004... BETHESDA, MD -- Although many biotech companies at a major conference here said they are already identifying potential impurities during Phase I processes, they called on FDA to make its expectations more transparent. FDAers said there is a...

'Excursions' become hot topic in stability programs, should be written in validation plans.(Stability)
July 1, 2004... PHILADELPHIA -- "Excursions" during stability testing have become so commonplace in drug manufacturing that companies ought to account for them in their validation plans and perform continuous validation, industry learned at the Center For...

'Quality by design,' predicting failures seen obviating stability-related recalls, NDA/ANDA holds.(Stability)
July 1, 2004... PHILADELPHIA -- Manufacturers ought to consider "quality by design" techniques in order to improve their stability testing, failures of which still account for a large number of recalls and NDA/ANDA review holds, a Pfizer executive suggested...

Commercial kits for assaying host-cell proteins not completely ready.(Assays)
July 1, 2004... BETHESDA, MD -- While FDA will accept commercial assays on a case-by-case basis, as well as in-house assays, neither the agency, nor industry, has enough experience with commercial assays to see if they are acceptable, particularly in tracking...

Multiple validation violations result in 26-item 483 for Indian firm.(Human drugs)
July 1, 2004... Granules India, Ltd., Jeedimetla Hyderabad, India, Center for Drugs Shipping products to the U.S. before initiating process validation studies and other validation violations resulted in a 26-item 483 to API-manufacturer Granules India,...

Topical drugmaker cited for production, quality system violations.
July 1, 2004... Island Kinetics, Inc., Tempe, AZ, Irvine District Island Kinetics, Tempe, AZ, was cited in a three-item 483 for production and quality system violations, including a lack of validations of production processes, equipment and cleaning of...

Drugmaker nets 12-item 483 for numerous GMP and validation violations.
July 1, 2004... Person & Covey, Glendale, CA, Los Angeles District Person & Covey, a prescription and OTC drug manufacturer, received a 12-item 483 for a number of GMP and validation deficiencies, notably a lack of both process and cleaning validation,...

Gel-Med International hit with 483 for validation process and quality problems.(Medical devices)
July 1, 2004... Gel-Med International, Kamanne Zehrovice, Czech Republic, Center for Devices Serious validation deficiencies were documented at Gel-Med's Czech Republic plant, landing the firm a six-item 483 following the September 2003 post-market PMA...

American Sunlight receives 483 and warning letter for QS violations.
July 1, 2004... American Sunlight, Inc., Huntington Beach, CA, Los Angeles District Mechanical- and powered-wheelchair manufacturer/refurbisher American Sunlight received a four-part 483 and warning letter for failure to establish, maintain and control an...

FDA cites tissue bank for deficient donor records.(Blood and biologics)
July 1, 2004... St. Luke's Hospital, Maumee, OH, Cincinnati District St. Luke's Hospital, a registered hospital tissue bank donor center, landed a three-item 483 for poor documentation records. Specifically, the tissue bank, which collects femoral heads...

Apptec Labs fails to prepare, validate written procedures.(Human drugs)
July 1, 2004... An FDA inspection determined Apptec Lab Services, St. Paul, MN, a contract human tissue processor, had numerous violations, including failure to prepare, validate and follow written procedures for prevention of infectious disease contamination...

Custom Industrial Analysis Labs deviates from drug GMPs.
July 1, 2004... An inspection of Custom Industrial Analysis Labs, a contract testing laboratory based in St. Joseph, MO, revealed significant deviations from the GMPs for finished pharmaceuticals. The May 18 warning letter listed violations, including...

Qualis hit with warning letter for GMP deviations.
July 1, 2004... Des Moines, IA-based Qualis received a June 23 warning letter noting serious deviations from current GMP regulations, notably failure to thoroughly investigate failures of finished drug products or drug product components to meet established...

Asahi Medical in violation of QS regs.(Medical devices)
July 1, 2004... During an inspection of Asahi Medical Co., Tokyo, an FDA investigator determined the manufacturer of hollow fiber capillary dialyzers and plasma filters was in violation of Quality System regulations. According to the June 3 warning...

Infusion pump maker Nipro in violation of QS rules.
July 1, 2004... FDA inspector Dianaris Ayala visited Nipro Diabetes System's Miramar, FL, location, and determined the specification developer of the Nipro GlucoPro Amigo Insulin Pump, an ambulatory pump intended for the subcutaneous infusion of insulin, was...

Orthoton cited for several QS regulation violations.
July 1, 2004... Orthoton, a manufacturer of T-Gear cervical headgear traction applications for orthodontic patients, received a warning letter because of several Quality System regulation violations at its Gorinchem, Netherlands, facility. The June 29...