Validation Times articles from February 2003

Validation Times archives from February 2003

FDA exempts pre-1997 legacy systems from most Part 11 enforcement, withdraws all guidance, may rewrite regulation; industry pleased. (Electronic records/signatures).
February 1, 2003... FDA gave drug and device industries a belated Valentine's Day gift Feb. 20 by announcing it would cancel all draft guidances and temporarily exempt from most regulatory action "legacy computers" that were in use before the August 1997 enactment...

FDA to create drug 'Pharmaceutical Inspectorate,' team audits; PAT advances. (Inspections/PAT).
February 1, 2003... FDA plans to mimic the "Team Biologics" approach to GMP inspections by creating a well-trained "cadre" of product specialists to join field investigators on audits, plus a new "Pharmaceutical Inspectorate," to coordinate human and animal drug...

More review 'specialists' seen on audits; CMC head wants ICH specs for IND drugs. (CMC).
February 1, 2003... PHILADELPHIA -- Drug manufacturers are likely to see more product reviewers during plant inspections, a top CDER official told a Drug Information Assn. (DIA) meeting here Feb. 11 just a week before FDA announced its new "Pharmaceutical...

Validation or qualification, the important thing is to show what FDA looks for. (Infrastructure Validation).
February 1, 2003... PHILADELPHIA--When it comes to network infrastructure, compliance becomes a bit of a word game. "Validation is well understood, but ask 10 different people about qualification and you will get 10 different answers," said Neil McClenney, project...

USP, FDA still deciding what is an 'adjustment' or 'modification' to methods, when revalidation needed. (Analytical methods).
February 1, 2003... PHILADELPHIA--FDA and the U.S. Pharmacopeia (USP) are still discussing when "adjustments" or "modifications" of operating conditions regarding system suitability requires revalidation, Eric Sheinin, Ph.D., USP vice president of information and...

Potential for failure should still guide Part 11 concerns with network infrastructure. (Electronic records/signatures).
February 1, 2003... PHILADELPHIA--Manufacturers should still focus on the potential for failure in their network infrastructure, despite recent FDA rethinking on Part 11. Kevin Martin and Tom Jacobs of CimQuest Systems Regulatory Compliance group, Exton, PA,...

Aventis dodges 483 despite validation protocol, Part 11 issues. (Human drugs).
February 1, 2003... Aventis Pharmaceuticals escaped a 483, despite validation deviations uncovered in its EKG software. The audit was initiated as a routine GLP/user fee inspection ordered by CDER. FDA inspector Byung Ja Marciante of the New Jersey District...

3M Northridge plant corrects 483s before warnings can be issued. (Human drugs).
February 1, 2003... While 3M Pharmaceuticals found itself unable to avoid the onus of 483s from 1999 to 2001, the company managed to correct a wide range of deficiencies before FDA could issue a warning letter. Investigators Louis Cencetti, James Fleckenstein...

Questionable OOS handling at American Pharm Partners raises eyebrows at FDA. (Human drugs).
February 1, 2003... A recent inspection of American Pharmaceuticals Partners' (APP) Melrose Park, IL, facility caused FDA to question the firm's handling of out-of-specification (OOS) results involving drug products. Chicago District investigators Yvonne...

Reprocessor gets clean bill of health, advice for complying with Part 11. (Medical devices).
February 1, 2003... Having sufficient hard-copy backup records was key in allowing single-use medical device reprocessor Alliance Medical Corp. to narrowly avoid a 483 for Part 11 deficiencies. Investigator Paul Whitby of the Los Angeles District inspected the...

Unvalidated design controls and faulty CAPAs may have caused patient electrode burns. (Medical devices).
February 1, 2003... Unvalidated design controls coupled with faulty corrective and preventive actions (CAPA) could have been key to electrodes which burned patients, according to findings from a July 8-11, 15 and 16, 2002, inspection of Mount Vernon, OH-based...

Searle hit for OOS in multiple validation lots. (Human Drugs).
February 1, 2003... A Dec. 27, 2002, warning letter cited Searle's Barceloneta, PR, facility for inadequate in-process controls in that during the validation of the manufacturing process for Plaquenil 200 mg tablets, two of the validation lots had out of...

Shaky process parameters focus of Vital Pharma audit. (Medical Devices).
February 1, 2003... Totowa, NJ-based Vital Pharma, Inc. received a Jan. 6 warning letter for not verifying or validating a change to a process for its Intergel Adhesion Prevention Solution product. In addition to this, the firm's Riviera Beach, FL, contract...

Surgical tray maker slips up on worst case scenario testing. (Medical Devices).
February 1, 2003... In an Aug. 1-6, 2002, audit of patient restraint/ sterile surgical tray maker E.M. Adams Co. Florida District investigator R. Kevin Vogel, uncovered validation deficiencies at the Fort Pierce, FL-based firm. Vogel wrote that E.M. Adams...

Dental implant maker bitten by unvalidated device history files. (Medical Devices).
February 1, 2003... FDA hit Biomedical Implant Technology with failure to validate its processes "with a high degree of assurance" and failure to establish and maintain a device history file (DHF) demonstrating one of its dental implants was developed in...

VBM hit for not validating manufacturing process, DHF. (Medical Devices).
February 1, 2003... FDA uncovered a failure by the VBM Medizintechnik GmbH to validate the process by which airway connector parts were manufactured with a high degree of assurance, the agency stated in a Dec. 13, 2002, warning letter. The agency also stated...