Validation Times articles from March 2005

Validation Times archives from March 2005

FDA, industry see drug standards impeding 'continuous improvement,' movement toward quality systems.(Drug specifications/standards)
March 1, 2005... BETHESDA, MD -- Top FDA officials and industry QA leaders strongly questioned the viability of drug standards in the new "quality systems" era, even implying they may impede the agency's goal for "continuous improvement" in pharmaceutical...

Nasr urges use of statistical methods, modeling to set specs; some are doubtful.(Drug specifications)
March 1, 2005... BETHESDA, MD -- At two separate speaking venues this month, Office of New Drug Chemistry Director Moheb Nasr, Ph.D., discussed a new paradigm for drug manufacturers setting specifications--through statistics and modeling, not end-product...

EU concept of 'release specification' seen limiting problems down road; 'desired state' concept urged.(Europe)
March 1, 2005... BETHESDA, MD -- Setting specifications in the European Union (EU) "feels" the most effective of the three International Conference on Harmonization (ICH) regions, said Pfizer's John Berridge, Ph.D., at the PQRI Workshop held here March 16-18....

Automated testing promising, but has its limitations, say industry experts.(Software)
March 1, 2005... PHILADELPHIA -- Software that tests software and other instruments can simplify the lab equipment validation process, but it may not be the panacea for every quality lab, executives told a Barnett International meeting here March 8. Nagesh...

Amgen, PharmaSys execs outline means to validate lab systems.(HPLC)
March 1, 2005... PHILADELPHIA -- Addressing some of the many challenges in qualifying and validating quality labs, industry lab experts Joe Mooney and Chris Haskett shared some recent case studies at Barnett International's Lab Equipment Validation and...

Better to get rid of spreadsheets, validate all instruments, Berlex lab manager suggests.(Inspections)
March 1, 2005... PHILADELPHIA -- A lab manager at Berlex said here March 8 that FDA will expect all lab instruments to be validated--although inspectors may only examine a few--and that companies should consider getting rid of spreadsheets because they are...

Bringing lab equipment qualification in-house via metrology saved Pfizer $200,000 in one year.(Metrology)
March 1, 2005... PHILADELPHIA -- By bringing its lab equipment qualification program in house using metrology helped save Pfizer $200,000 in one year, but the entire process took two years and was considered very laborious. Louis Dupont, an analytical...

CDER's Nasr sees reviewers joining in on audits, MAPP template for CMC reviews.(CMC)
March 1, 2005... Office of New Drug Chemistry Director Moheb Nasr, Ph.D., told an ExpertBriefing.org audioconference March 10 that his group will soon be renamed the "Office of New Drug Quality Assessment" and that CMC reviewers will be joining inspectors on...

Integra Chemical cited in 483 for equipment failures.
March 1, 2005... Integra Chemical Company, Renton, WA, received an 11-item 483 because its equipment "is not adequate for repacking APIs." The firm is a repackager of bulk APIs, including acetaminophen, aspirin, calcium carbonate and other chemicals. ...

O'Farrell slapped with 13-item 483 for instrument calibration flaws; owner blasts agency.
March 1, 2005... Wallace O'Farrell, Puyallup, WA, received a 13-item 483 and warning letter because instrument calibration was not conducted at suitable intervals, and for not keeping records for the cleaning and sanitizing of equipment. Investigator Carl...

Tyco Healthcare/Kendall hit with 3-item 483 for failure to follow validation procedures.(Medical devices)
March 1, 2005... A three-item 483 was issued to Tyco Healthcare/ Kendall, Argyle, NY, for failing to follow procedures for the validation or verification of design changes before their implementation. An April 21, 2003, warning letter also was issued to the...

Mercy Medical hit with 5-item 483 for Part 11 flaws, inadequate process control procedures.(Biologics)
March 1, 2005... The blood bank at Mercy Medical Center, Baltimore, MD, was issued a five-item 483 for electronic records failures, including not checking the accuracy of computer input and output, not validating computer equipment, and the inability to provide...

Byran Co. cited for QS, CAPA violations.(Medical devices)
March 1, 2005... An inspection of The Byran Co., Huntington Beach, CA, Sept. 16, 22, 28 and 30, 2004, revealed that the manufacturer of Class I and Class II implantable surgical spine screws, rods and other orthopedic devices used during surgery, had not...

EDS lacks plan to implement CAPA procedures.
March 1, 2005... An inspection of Electronic Data Systems' (EDS) Falls Church, VA, facility Sept. 13 through Oct. 5, 2004, determined that the manufacturer of the Defense Blood Standard System (DBSS) software, version 3.04, was not in conformance with current...

Lar Manufacturing fails to establish QS system.
March 1, 2005... During an inspection of the Lar Manufacturing in Port Richey, FL, Oct. 1-4, 2004, an FDA investigator determined that the manufacturer of ceramic dental brackets was in violation of QS regulations. Deviations included that an effective...

Device manufacturer cited for lack of CAPA procedures.
March 1, 2005... During an inspection of the Medsep Corp. in Corvina, CA, from Aug. 2-Sept. 9, 2004, investigators determined that the firm, a manufacturer of the Bacterial Detection System and the Enhanced Bacterial Detection System, was not in conformance...

Specification developer cited for inadequate quality audits.
March 1, 2005... An inspection Dec. 6-15, 2004, showed that The Sporicidin Company, Rockville, MD, violated current GMP requirements. The firm is a specification developer of sterilization products. Violations included that the firm's management reviews did...

Allergy Labs of Ohio fails to follow SOPs.
March 1, 2005... Allergy Labs of Ohio, Columbus, OH, FDA inspection of Nov. 1-4, 2004, revealed several objectionable conditions relating to the facility's compliance with current GMPs. Significant deviations in the manufacture of allergenic source...