Validation Times articles from September 2004

Validation Times archives from September 2004

FDA guidance on drug QS to emphasize management responsibilities, resources, operations and evaluation actions.(Quality systems)
September 1, 2004... WASHINGTON -- FDA's long-awaited final report, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach," which intends to push the human and animal drug industry into the 21st century while the agency figures out how to rewrite its...

Final FDA guidance not strict on 0.5-micron particle size 'requirement,' is in line with ISO.(Aseptic processing)
September 1, 2004... WASHINGTON -- FDA's final guidance on aseptic processing is harmonized with International Standards Organization (ISO) standards but will not have strict 0.5-micron particle-size recommendations, said Center for Drugs compliance officer Rick...

'Council on Pharmaceutical Quality' to be created at FDA, chemistry reviews to be reformed.(CMC)
September 1, 2004... WASHINGTON -- FDA plans to create an internal "Council on Pharmaceutical Quality" to oversee a new "pharmaceutical quality review paradigm," including means to reduce the number of supplements that firms must submit to make improvements in...

Facets of drug GMPs to be redone; FDA pushes ICH quality initiatives, industry to offer validation paper.(GMP Regulations)
September 1, 2004... WASHINGTON -- Despite rolling out its "Pharmaceutical GMPs for the 21st Century Initiative" in August 2002, FDA topsiders have long emphasized there is no need to rewrite the drug GMPs (21 CFR Parts 210, 211), contending the regulations written...

Don't expect PAT to be 'instantaneous success,' Pfizer exec says.(Process analytical technology)
September 1, 2004... WASHINGTON -- A Pfizer manager Sept. 22 outlined how his firm is using PAT and working with FDA under a cooperative agreement to encourage its use throughout the drug and biologic industries. But Joep Timmermans, Ph.D., senior manager in...

FDA letting industry determine how to roll out RFID; validation, CBE requirements noted.(Counterfeiting/packaging)
September 1, 2004... Since recommending radio frequency identification (RFID) tags as a promising track and trace technology last January to thwart counterfeiting, FDA appears to have stepped back to let industry determine how best to develop that technology for...

Process validation violations result in 10-item 483, warning letter for pharmaceuticals plant.(Human drugs)
September 1, 2004... Multiple process validation violations resulted in a 10-item 483 for Vintage Pharmaceutical's new plant in Huntsville, AL, plus a warning letter. The initial inspection of the plant, which produces tablets and capsules, was conducted by...

OOS violations cited in 12-item 483 for Care-Tech Labs.(Human drugs)
September 1, 2004... Seven voluntary corrections since its previous inspection did not prevent Care-Tech Labs, St. Louis, MO, from receiving a 12-item 483 for a lack of OOS investigations/reports and for releasing products for distribution that did not meet...

Clinical Pharmacies hit with 15-item 483 and warning letter for 'significant QS regulation deficiencies'.(Medical devices)
September 1, 2004... A February-March inspection of Clinical Pharmacies, Huntington Beach, CA, revealed a lack of documentation for validation activities and results and other "significant Quality Systems regulation deficiencies," resulting in a 15-item 483 and...

Gentere produces unlicensed drugs, violates pharmacy compounding act.(Human drugs)
September 1, 2004... A joint FDA/Ohio State Board of Pharmacy inspection concluded that Gentere, Inc., dba Teregen Labs, Willoughby, OH, was producing and distributing unapproved new injectable drugs without valid prescriptions for individually identified patients...

Agency cites Pharma Fab for inadequate sterilization procedures.(Human drugs)
September 1, 2004... Pharma Fab, Grand Prairie, TX, was cited for failure to clean, maintain and sanitize equipment and utensils at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of...

Ultra-Seal found to have numerous labeling inaccuracies, stability issues.(Human drugs)
September 1, 2004... FDA inspector Demitria Argiropoulos visited Ultra-Seal Corp., New Paltz, NY, between March 2-8 and found significant deviations from GMP regulations for finished pharmaceuticals, including that labeling materials were not being carefully...

Contaminated culture media bottle may have been cause of febrile convulsion, agency says.(Blood/biologics)
September 1, 2004... During an April 13-30 inspection, FDA determined BioMerieux, Inc., Durham, NC, failed to adequately perform validation according to established procedures. Specifically, the manufacturer of immuno-diagnostic, hemostasis and microbiology...

Crystal Labs allergenic, mold-source material fails to meet GMP standards.(Blood/biologics)
September 1, 2004... FDA inspectors determined during a May 5-7 inspection that Crystal Laboratory, Inc., Luther, OK, was not following current GMPs and applicable standards for the manufacture of allergenic, mold-source material. According to the Aug. 6 warning...

Orthopedic implant manufacturer lacks adequate software validation procedures, complete DMRs.(Medical devices)
September 1, 2004... A Jan. 26-29 inspection of Aap Implantate AG, Berlin, revealed the manufacturer failed to validate according to an established protocol, computer software for its intended use, when that software was used as part of the Quality System as...

Extended Care Air Therapy lacks design change procedures for identification, documentation, validation.(Medical devices)
September 1, 2004... Failure to establish procedures to control the design process for the identification, documentation, validation or verification, review, and approval of design changes before their implementation was chief among violations determined during a...

Bio Compression lacks design verification, validation procedures; fails to submit 510(k) for modified medical device.(Medical devices)
September 1, 2004... An FDA inspector visiting Bio Compression Systems, Moonachie, NJ, March 2-15, determined the manufacturer of sequential circulators and compression therapy garments had failed to implement required manufacturing procedures. According to...

FDA cites Inceptio Medical for allowing off-site validation activities.(Medical devices)
September 1, 2004... Significant among GMP deviations for which Inceptio Medical Technologies, L.C., Kaysville, UT, was cited following an April 28-May 7 audit was the lack of an in-house, sterilization validation process for its Punctsure Vascular Access Imaging...

Dental product manufacturer lacks procedures for validating device design.(Medical devices)
September 1, 2004... Glustitch Inc., Delta, BC, Canada, neglected to have adequate validation procedures for its dental cements, skin protectants and liquid bandages, FDA determined during a March 15-18 inspection. Specifically, the manufacturer had failed to...