Validation Times articles from October 2004

Validation Times archives from October 2004

FDA won't scrap Part 11, will continue to refine guidance based upon industry feedback.(Electronic records)
October 1, 2004... WASHINGTON -- FDA will not eliminate CFR Part 11 guidance, as some industry comments on the federal docket have urged, because to do so would effectively cede control of the policy to the Department of Justice (DOJ). "This is the last...

FDA delays guidance on how to market lower-cost copies of biotech drugs.(Follow-on biologics)
October 1, 2004... FDA's long-promised draft guidance on follow-on biologics--also called follow-on proteins, biogenerics and biosimiliar products, or "generic biologics"--has been delayed until after public workshops are completed, effectively postponing any...

Validation to focus on microbiological growth medium in place of drug product; inspection guide forthcoming.(Aseptic processing)
October 1, 2004... WASHINGTON -- A key facet of FDA's new aseptic processing guidance released in September is to move validation based on "microbiological growth media" versus actual drug products, according to the Center for Drugs staffer who has been...

International collaboration, ASTM playing vital role in new PAT guidance.(Process analytical technology)
October 1, 2004... There are strong signs that FDA's September process analytical technology (PAT) guidance is drawing significant international backing, as international regulators are beginning to form PAT teams in Canada, Europe and Japan; and the guidance is...

ASTM has finalized terminology, now focusing on risk management with PAT.(Standards)
October 1, 2004... PHILADELPHIA -- ASTM committee (E55) has finalized terminology for PAT and its subcommittee (E55.01) and is working on a standard practice for risk management as it impacts the design and development of processes for pharmaceutical manufacture,...

U.S., Europe panels moving towards cold chain harmonization, despite May setback.(Cold chain distribution)
October 1, 2004... PHILADELPHIA -- While the American Pharmaceutical Cold Chain Discussion Group (PCCDG) and the equivalent European Cold Chain Committee (C3) did not meet their goal of harmonizing guidances by May 2004, members are still hopeful that...

Increasingly complex supply chain, inattention to final links pose problems, experts say.(Packaging)
October 1, 2004... PHILADELPHIA -- Citing increasingly complex supply chains and more regulations as challenges for manufacturers, experts gathered at IOPC's Second Annual Cold Chain Distribution for Pharmaceuticals conference held here Oct. 19 to discuss the...

FDA seeks to reduce PAS, CBE workload through protocols.(Comparability protocols)
October 1, 2004... The guidance for comparability protocols, released with the agency's Final Report "Pharmaceutical cGMPs for the 21st Century--A Risk-Based Approach," was developed to identify options for a systematic risk-based approach to the review process...

Case Western Reserve hit with 11-item 483 for failure to maintain records for equipment calibration, QA flaws and GLP testing violations.(GLPs)
October 1, 2004... Case Western Reserve University, Cleveland, received an 11-item 483 and an April 16 warning letter for not "maintaining records for the maintenance and calibration of equipment," quality assurance flaws and numerous GLP testing violations after...

Audit yields Cardiac Science 483 and warning letter for QS and CAPA faults.(Medical devices)
October 1, 2004... Cardiac Science, Minneapolis, MN, was cited in a five-item 483 and a subsequent March 29 warning letter for QS and CAPA violations, and also for various verification and validation flaws. FDA stated in the 483 that an unspecified recall...

Acupuncture needle exporter receives 12-item 483, warning letter for validation, CAPA, MDR violations.(Medical devices)
October 1, 2004... Failing to validate a process according to established procedures, develop written MDR procedures or establish procedures for implementing CAPAs netted Electro Therapeutic Devices, Markham, ON, Canada, a 12-item 483 following a January...

Natureplex cited for cleaning, container closure issues for OTC products.(Human drugs)
October 1, 2004... Natureplex, LLC, Memphis, TN, was found to be in violation of current GMPs, primarily cleaning validation and container-closure issues, according to an Aug. 18 warning letter. Natureplex produces ophthalmic drug products Eye Drops Allergy...

Delta Pharma found compounding in large scale, copying other drugs.(Human drugs)
October 1, 2004... Delta Pharma, Inc., Ripley, MS, was compounding human drugs in large-scale production, making copies of commercially available FDA-approved products and could not document a medical need for particular patients for their versions of otherwise...

Software validation, CAPA faults, lack of FDA approval cited at Daavlin.(Medical devices)
October 1, 2004... An FDA warning letter to Daavlin Distribution Co., Bryan, OH, cited the maker of phototherapy units for software validation, plus other violations of the GMP/Quality Systems rule for medical devices. Daavlin manufactures various...

QS, software validation, MDR faults cited at General Medical.(Medical devices)
October 1, 2004... During an inspection of General Medical Co., Los Angeles, CA, on July 20, 21 and 29, FDA investigator Kirtida Patel found that the company was not in conformity with the QS regulation and Medical Device Reporting (MDR) regulations. Failure to...

Terumo hit with QS violations, chiefly, CAPA.(Medical devices)
October 1, 2004... A May 10-18 inspection of Terumo Cardiovascular Systems Corp., Ann Arbor, MI, revealed that the methods used in, or the facilities or controls used for their manufacture, packing, storage or installation at the facility were not in conformance...

Mold, filth, air-handling problems cited at arterial blood gas sampling kit maker in Mexico.(Medical devices)
October 1, 2004... Westmed de Mexico, S.A. Tecate, Mexico, the manufacturer of arterial blood gas sampling kits, was issued a warning letter Aug. 12 for failure to conform to Quality System requirements. The letter noted the kits were adulterated because they...

Piedmont Hospital fails to follow procedures, report BPDs.(Biologics)
October 1, 2004... An inspection of the blood transfusion service at Piedmont Hospital, Atlanta, revealed numerous deviations from applicable current GMP regulations for blood and blood components, thus causing FDA to declare the blood products adulterated. ...