Validation Times articles from August 2004

Validation Times archives from August 2004

Forthcoming guidance to show gradual GMPs for IND drugs, but also cover starting materials.(Clinical supplies)
August 1, 2004... CHERRY HILL, NJ -- A forthcoming Center for Drugs guidance on clinical supplies--which could appear on FDA's website within a month--will generally support manufacturers gradually increasing GMPs depending on IND drug study phase, but FDA will...

FDAer says record-retention for audits can be in paper, no need for passwords on each system if SOPs dictate.(Electronic records)
August 1, 2004... WASHINGTON -- Manufacturers can use paper records for audit trails and not have a password for each computer if their SOPs state there is access by one person, a Center for Drugs compliance official told a recent conference regarding FDA's new...

'Training effectiveness' seen important to FDA, especially in clinical manufacturing.(Training)
August 1, 2004... CHERRY HILL, NJ -- Training personnel in the manufacturing of experimental drugs used in clinical trials needs to be better, but also, FDA is looking more at how industry assesses "training effectiveness." That's the word from Douglas...

Experts see European directive as good model for clinical supply rules; Japan changing, too.(International)
August 1, 2004... CHERRY HILL, NJ -- Europe and Japan could very well set the mode for how GMPs will apply to clinical supplies, at least according to pharmaceutical industry executives who addressed AAPS' conference on the topic here Aug. 15-20. David...

Cardinal Health develops policy and guidelines to implement new European regulations.(EU directive)
August 1, 2004... CHERRY HILL, NJ -- Cardinal Health is attempting to harmonize GMP standards at all of its European facilities and has upgraded other GMP auditing efforts as well, all in response to the May 1 EU Directive. Addressing AAPS Aug. 18, Mary...

Anderson Pharmaceuticals cited for misbranding, water, batch record and packaging issues.(Human drugs)
August 1, 2004... Water quality, batch records and packaging issues topped GMP-related citations on a 483 and warning letter issued to Anderson Pharmaceuticals, Norwich, NY, following a September 2003 audit of the contract OTC drugmaker. Investigators...

No 483 for research lab, but validation, HPLC issues noted.(Human drugs)
August 1, 2004... Investigator Jawaid Hamid of the Atlanta District Office conducted a second inspection of Southern Testing & Research Lab, Wilson, NC, and noted that "all investigations were found to be adequate," but he noted in the EIR that "HPLC systems do...

Satelec Acteon Group hit with 483 and warning letter for process validation, QA deficiencies.(Medical devices)
August 1, 2004... Satelec Acteon Group, Merignac, France, was slapped with a 483 by Claudette Brooks of the Rockville, MD, office and a subsequent warning letter because the firm failed to fully document process validation activities and also because it did not...

Testing facility cited for GLP violations.(Blood/biologics)
August 1, 2004... BioDevelopment Associates, Bellevue, WA, was cited in a July 2 warning letter for numerous GLP violations for Nonclinical Laboratory Studies. According to the letter, the non-clinical testing facility failed to inspect each study at...

Bayer Healthcare releases non-conforming urine chemistry analyzers for distribution.(Medical devices)
August 1, 2004... Bayer Healthcare, Mishawaka, IN, was cited in a June 17 warning letter because non-conforming Clinitek 50 urine chemistry analyzers, built by an operator who had failed to install grounding straps, were released and distributed, despite a...

Diamedix fails to investigate, correct non-conforming product.(Medical devices)
August 1, 2004... Diamedix Corp., Miami, FL, failed to investigate, determine and correct recurrence of product non-conformities or potential causes of non-conformities requiring investigation, trend analysis, review by management and CAPA, according to a June 3...

Wheelchair equipment not routinely calibrated, inspected, maintained.(Medical devices)
August 1, 2004... Everest and Jennings LaBac Systems, Denver, CO, did not have procedures in place to ensure that its manual and powered wheelchairs and wheelchair equipment were routinely calibrated, inspected, checked and maintained. This put potential users...

Spinal Concepts fails to adequately validate thoracolumbar systems, vertebral replacement devices.(Medical devices)
August 1, 2004... A June 21 warning letter cited Spinal Concepts, Austin, TX, for failure to establish and maintain device design validation procedures that ensured devices conformed to defined user needs and intended uses, and failure to include plans for...

Medical device sterilizers simultaneously cited for validation problems.(Medical devices)
August 1, 2004... In a June 15 warning letter, FDA noted that two Steris Isomedix Services facilities in Libertyville, IL had neither process validation activities and results nor evaluations and investigations of non-conforming product, as required. The...