Validation Times articles from December 2004

Validation Times archives from December 2004

FDA background document on follow-on 'protein pharmaceuticals' seen by January, draft guidance to follow in early spring.(Follow-on biologics)
December 1, 2004... RESTON, VA -- FDA next month is expected to release a background document on follow-on protein pharmaceuticals (i.e., follow-on biologics) and a draft guidance document in February, thus starting what could become "generic biologics." ...

CHPA guideline on OTC drug stability testing still under development.(Stability)
December 1, 2004... The Consumer Health Products Assn. (CHPA) is still developing a guideline on stability testing requirements for over-the-counter (OTC) drug products in absence of an FDA guidance document. The CHPA document, however, is still under...

Mammalian cell technology improving, expert notes; 1-4g/L realized now, 5-10g/L expected soon.(Biotech)
December 1, 2004... RESTON, VA -- Mammalian cell technology has improved rapidly in recent years, with 1-4g/L being achieved today, and 5-10g/L expected in the near future, said Bill Whitford, a senior manager at Hyclone Research and Product Development in Logan,...

Training IT personnel, improving documentation are critical for compliant networks.(Computer/software)
December 1, 2004... PHILADELPHIA -- Drawing from recent 483s and warning letters, Bob McDowall, Ph.D., a consultant based in Bromley, Kent, U.K., has found that the biggest hurdles for compliant networks are improperly-trained IT personnel and inconsistent...

Multidisciplinary approaches, pared down SOPs can simplify network qualification.(Network qualification)
December 1, 2004... PHILADELPHIA -- For U.K. consultant Bob McDowall, the IT network and infrastructure is the iceberg, of which GXP business applications are the tip. "With 'qualification' you want to work smarter, not harder," he told the Nov. 15 RCWG...

2-item 483 to Cardinal Health cites lack of lab determination of conformance to final specs, OOS.
December 1, 2004... Cardinal Health Manufacturing Services in Humacao, PR, was recently hit with a two-item 483 for failing to appropriately determine satisfactory conformance to final specifications prior to their release to market, in other words,...

Taiwan API maker gets 12-item 483 for validation, OOS, calibration violations.
December 1, 2004... A 12-item 483 for validation failures, unacceptable OOS procedures and equipment calibration flaws was given to Yung Shin Pharmaceutical Industry, Tachia, Taiwan. The inspection was conducted by George Flynn from the Center for Drugs. Yung...

IVD maker slapped with 4-item 483 for failing to validate processes, document validation activities.(Medical devices)
December 1, 2004... Failing to "validate processes and document the validation activities and results" netted a four-item 483 for IND Diagnostics, Delta, BC, Canada, following an inspection by Dannie Rowland from FDA's Center for Devices. IND manufactures in...

Boehringer Ingelheim Vetmedica lacks sampling, testing to validate performance.(Human/animal drugs)
December 1, 2004... Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO, was cited, following a July 19-29 inspection, for failure to have adequate sampling and testing to validate the performance of its veterinary pharmaceutical manufacturing processes that...

Lowlyn Pharmacies found compounding outside VCPR.
December 1, 2004... Following a May 17 and 26 inspection, Lowlyn Pharmacies, Inc., Blanchard, OK, a veterinary drug compounding operation, was found to be compounding and distributing veterinary drugs, including Nitrofurazone, Enrofloxacin HCL, Omeprazole,...

Shin Chang Medical lacks validation for sterilization, CAPA.(Medical devices)
December 1, 2004... Shin Chang Medical Co., Ltd., Gumi-Shi, Kyungsangbuk-Do, Republic of South Korea, failed to validate and approve according to established procedures a process whose results could not be fully verified by subsequent inspection and testing. ...

American Diagnostica lyophilization process not validated.
December 1, 2004... In an Oct. 15 warning letter, FDA stated that American Diagnostica, Stamford, CT, did not validate the lyophilization process used in manufacturing its in vitro diagnostic devices (IVDs). Also, the agency found during its Aug. 2-5 and 10...

Computerized Radiation Scanners lacks procedures for validating device design.
December 1, 2004... Computerized Radiation Scanners, Inc., Vero Beach, FL, which manufactures radiation beam scanner devices, was found to have deficiencies in its application of the QS regulation, following a July 19-20 visit by Florida District inspectors. The...

Process, software validation CAPA faults cited at Clarity.
December 1, 2004... Failure to validate processes, software validation activities, and CAPA issues topped GMP-related citations on a 483 and warning letter issued to Clarity Inc., Memphis, TN, following an Aug. 19-25 inspection of the manufacturer of otologic...

Germiphene process validation inadequate.
December 1, 2004... An FDA inspector visiting the Germiphene Corp. facility in Brantford, ON, Canada, from June 14-16 determined that the firm was not following current GMPs and applicable standards for the manufacture of dental device cleaners and ozonating water...

Agency cites Blood Net for equipment maintenance, calibration faults.(Blood/biologics)
December 1, 2004... A Nov. 2 FDA warning letter to Blood Net USA, Inc., Lakeland, FL, cited the licensed, full-service blood bank and contract-testing lab for failure to maintain schedules and procedures for equipment maintenance and calibration, plus other...