Validation Times articles from March 2004

Validation Times archives from March 2004

FDA set to hold June hearing on whether to redo Part 11 regulation.(Electronic records)
March 1, 2004... ATHENS, GA -- FDA has tentatively set a June 11 date for a conference to discuss whether to rewrite the agency's 1997 electronic signature/records regulation (21 CFR Part 11), but in a meeting here March 16 the lead contact for Part 11 at the...

FDA to publish final GMPs for 21st century guidance by August, adverse events remain top FDA priority.(GMP initiative)
March 1, 2004... WASHINGTON -- FDA is on track to publish a final guidance in August regarding its "Pharmaceutical GMPs for the 21st Century Initiative," Acting Commissioner Lester Crawford, Ph.D., told attendees of the Consumer Healthcare Products Assn. (CHPA)...

'Real time' QA is goal of FDA's efforts for 'quality by design'.(Risk management)
March 1, 2004... ATHENS, GA -- The director of FDA's field drug committee--and a key player in the agency's "Pharmaceutical GMPs for the 21st Century Initiative"--said pharmaceutical manufacturers need to move toward "real time" QA through "quality by design,"...

Quality agreements spell out roles; FDAers eager for them.
March 1, 2004... ATHENS, GA -- As part of its efforts to bring a quality systems approach to drug/biologic QA/QC, FDA appears to be interested in firms adopting "quality agreements." Addressing the University of Georgia's international GMP meeting here...

FDAer sees final aseptic guide soon, curriculum for Inspectorate; PAT efforts updated.(Aseptic Processing/PAT)
March 1, 2004... ATHENS, GA -- FDA is expected to issue a final guidance on aseptic processing and provide a final curriculum for its Pharmaceutical Inspectorate, which is designed to combine CDER, Center for Biologics and Center for Veterinary Medicine audits....

Process validation, lack of qualification among quality system failures cited in Alpharma 59-item 483.(Human drugs)
March 1, 2004... Numerous process validation deficiencies and lack of qualification data as well as other serious quality issues landed human-drug maker Alpharma USHP, Baltimore, a whopping 59-item, 24-page 483. According to the 483, prepared by a team led...

Validation, testing deficiencies result in 483 for Austrian firm.(Human drugs)
March 1, 2004... Austrian firm Biochemie GmbH, Kundl, Austria, received a four-item 483 for testing and validation deficiencies following a pre-approval inspection for two sterile bulk NDAs. James Giefer and Kevin Kallander from the Center for Drugs Office of...

IVD exporter caught with 'cat in the bag,' as FDA warns firm about rodent control, QS deficiencies.(Medical devices)
March 1, 2004... FDA found Eagle Diagnostics of Cedar Hill, TX, was using a cat for "rodent control," along with other violations of the GMP/Quality System (QS) regulations. Dallas District investigators Sherrie Krolczyk and Cynthia Harris handed the in...

Quality control failures result in 483, warning letter for blood bank.(Blood & Biologics)
March 1, 2004... Mississippi Blood Services, Jackson, MS, received an eight-item 483 from FDA for serious lapses in quality control and documentation following an audit conducted by Eddie Rigsby of FDA's New Orleans District. The blood bank received a...

Drug manufacturer hit with laundry list of validation, quality violations.(Human drugs/biologics)
March 1, 2004... Failure of Almil Nutritional Products, Brea, CA, to validate equipment used to manufacture and process human drugs was one of many deficiencies cited by FDA in a Feb. 2 warning letter. According to the letter, FDA found deficiencies in the...

CDER notes significant GMP deviations in firm's manufacture of APIs.(Human drugs/biologics)
March 1, 2004... Shanghai Medical Ltd. got a Feb. 10 warning letter from the Center for Drugs after FDA investigator Robert Horan, Ph.D., and chemist Susan Ting determined significant GMP deviations in the manufacture of active pharmaceutical ingredients...

Eye Bank cited for deviations from regulations for human tissue for transplantation.(Human drugs/biologics)
March 1, 2004... FDA determined that Rocky Mountain Lions Eye Bank, Aurora, CO, was not maintaining records documenting the destruction or other disposition of human tissue and was not following procedures for designating and identifying quarantined tissue,...

Respironics uses unvalidated, untested software.(Medical devices)
March 1, 2004... Design validation activities conducted for the Respironics' "Esprit" microprocessor-controlled, electrically powered mechanical ventilator software version 3.2 failed to ensure that the device conformed to the defined user/patient needs and...

Ocuserv neglects to validate software transfer process for ophthalmic autoscan system.(Medical devices)
March 1, 2004... Software validation was the principal concern noted by FDAers following a Jan. 13, 14 and 23 inspection at Ocuserv Instruments, Jamaica, NY, which resulted in a warning letter dated March 2. Agency investigators found that the manufacturer...

Osteomed fails to validate device design.(Medical devices)
March 1, 2004... Failure to validate device design--including testing under actual or simulated use conditions as required--was probably Osteomed's, Addison, TX, most serious violation. According to the Feb. 11 warning letter, the manufacturer of bone...

Cervical dilator manufacturer cited for inadequate validation processes.(Medical devices)
March 1, 2004... FDA's Center for Devices determined that Gel-Med International, Kamenne Zehrovice, Czech Republic, to complete the its own cleaning validation and utilized inadequate validation processes for the company's injection molding and water system....

Cardio Display lacks calibration documentation.(Medical devices)
March 1, 2004... Cardio Display Corp., Port Washington, received a warning letter after FDA discovered the company's service reports did not include applicable test and/or inspection data. In addition, the agency said there was no documentation of...

FDA cites Obsidian for sundry QS violations.(Medical devices)
March 1, 2004... Chief among the numerous QS regulation violations that landed Obsidian Medical Technology, Dublin, CA, in hot water was that the manufacturer had failed to establish and maintain an adequate organizational structure to ensure that devices were...

Lack of MDR procedures, poor quality system lands dental firm warning letter.(Medical devices)
March 1, 2004... Poor quality system management was among several GMP deviations found at at Makevale Ltd., Hertfordshire, U.K., following a CDRH audit Sept. 1-3, 2003. According to the Jan. 30 warning letter, the manufacturer of dental polymers and...

Satelec Acteon fails to establish protocol for sterilization validation.(Medical devices)
March 1, 2004... Failure to fully document process-required validation activities and results, specifically in regard to sterilization validation activities, resulted in Satelec Acteon Group's, Merignac, France, receipt of a warning letter Jan. 20. During...