Validation Times articles from December 2007

Validation Times archives from December 2007

New China agreements mark important steps in boosting safety of imported active pharmaceutical ingredients.(APIs/imports)
December 1, 2007... Secretary of Health and Human Services (HHS) Mike Leavitt's December trip to China resulted in the signing of two agreements with the Chinese government that mark important first steps in increasing the safety controls on active pharmaceutical...

FDA IT infrastructure 'problematic at best, dangerous at worst,' agency subcommittee reports: recommends development of risk-based models for selecting inspection sites.(IT/electronic records)
December 1, 2007... A new FDA-requested report released Dec. 4 stated that FDA's information technology (IT) infrastructure is problematic at best and dangerous at worst, leading to cases where reports of product dangers are not rapidly compared and analyzed,...

Electronic signature policy key to submitting properly formatted eCTD.(Electronic clinical trials)
December 1, 2007... With the agency's Jan. 1 deadline requiring the use of the eCTD format for electronic submission of NDAs looming, companies need to be sure they are ready to submit eCTDs properly--including policies, procedures and technology to handle...

7-item 483 cites King Pharma production and process control flaws.(Human drugs)
December 1, 2007... King Pharmaceuticals, Bristol, TN, was slapped with a seven-item 483 written production and process controls were not followed, and no acceptance criteria were used for the qualification of dryers. Edward Maticka from the Nashville, TN,...

Martec nets 483 for inadequate laboratory controls.
December 1, 2007... Martec Scientific, Kansas City, MO, was hit with a 22-item 483 because laboratory controls were flawed. Investigators Daniel Hutchison, Shirley Berryman, Michele Obert and chemist Raymond Valdivia performed the investigation for the Lenexa, KS,...

Poor environmental monitoring, sampling flaws net 483 for Sparhawk.
December 1, 2007... Sparhawk Laboratories, Lenexa, KS, received two 483s following recent FDA audits, one which cited the firm's environmental monitoring program during aseptic filling operations, and the other, inadequate representative sampling of each shipment...

Amerifit cited for faulty test procedures in letter.(Human drugs)
December 1, 2007... An inspection conducted by FDA April 10--May 10 at the drug manufacturing facility of Amerifit Brands, Cromwell, CT, revealed several deviations from GMPs, including a failure to confirm that each batch of drug product conformed to final...

Ben Venue fails to establish written control procedures.
December 1, 2007... An FDA inspection May 7--June 15 Ben Venue Laboratories, Bedford, OH, revealed several deviations from GNP regarding the manufacturing of Propofol Injectable Emulsion. The agency's investigation found a failure to establish written control...

E Med warned for failing to maintain quality system.(Medical devices)
December 1, 2007... During an FDA inspection conducted July 9-25, it was determined that E Med Future's manufacture of needle disintegration devices (NeedleZap) was not in compliance with GMP/Quality Systems rules. The inspection at the Millersburg, OH,...

Validation failures trip up Troy Innovative Instruments.
December 1, 2007... FDA conducted an inspection of Troy Innovative Instruments, Middlefield, OH, Sept. 6-27 and determined that the manufacture of various tools and implantable orthopedic and neurological devices were not in conformance with GNP/QS regulations....