Validation Times articles from August 2006

Validation Times archives from August 2006

Post-approval changes often unnecessary, continuous improvement could avoid them; guidance in offing.(CMC)
August 1, 2006... PHILADELPHIA -- Many product Changes made in the post-approval world are reactive in nature, usually due to FDA observations or product Failure. These changes can be avoided through continuous improvement, such as, analysis of a database of...

Patient harm not key in prosecutions, U.S. attorney says.(Compliance/enforcement)
August 1, 2006... CAMBRIDGE, MA -- In the prosecution of violations of FDA regulations, harm to patients may be excluded from the judiciary process. Those are startling words on the surface, but as James Sheehan, associate attorney in the U.S. Attorney's...

Part 11 risk assessment 'not an alternative' to compliance with predicate rules.(Electronic records)
August 1, 2006... PHILADELPHIA -- When conducting a risk assessment of computer systems for compliance with 21 CFR Part 11 pertaining to electronic records, it is important to think of risk in how it applies to your patient, product or safety. What you should...

Big pharma to begin rollout of SAFE electronic sig system in 2007.(Electronic records)
August 1, 2006... PHILADELPHA -- The Secure Access For Everyone (SAFE) initiative--an industry effort to create a trusted, secure and legally enforceable electronic signature application for business and clinical transactions--will be rolled out more...

Validation plan should include risk prioritization of all company systems, says Acambis quality exec.(Master planning)
August 1, 2006... ARLINGTON, VA -- It is vital that a system-validation, master plan include a validation program for every computer system in a company, each of which should be prioritized according to risk, with a complete justification of that ranking, the...

Technology seen as 'holy grail' in tracking products, improving product validation.(RFID)
August 1, 2006... CAMBRIDGE, MA -- Radio-frequency identification (RFID), which FDA and industry have pushed as a means of thwarting counterfeiting of prescription and OTC drugs, was hailed at a conference here Aug. 24 as a means of also improving pharmaceutical...

23-item 483 for Allergy Labs citing aseptic processing, sanitation procedures, equipment cleaning.(Human drugs)
August 1, 2006... Allergy Laboratories, Oklahoma City, received a 23-item 483 for its sterile drug manufacturing facilities because its aseptic processing areas were deficient regarding the system for monitoring environmental conditions. Further, its written...

Lack of acceptance criteria and validation flaws nets 6-item 483 for American I.V.
August 1, 2006... American IN. Products (AIV), Hanover, MD, was hit with a six-item 483 because it failed to establish acceptance criteria prior to the performance of validation activities, and also prior to the performance of verification activities. ...

Andrx Pharma on receiving end of 9-item 483 for OOS, QC violations, control procedures.
August 1, 2006... Andrx Pharmaceuticals, Ft. Lauderdale, FL, was slapped with a nine-item 483 in a March-April inspection because it did not perform investigations of OOS results. Also, the firm's quality control unit was inadequate, and the firm had faulty...

Several firms receive warning letters for questionable erectile dysfunction drug claims, including sildenafil.(Human drugs)
August 1, 2006... FDA in July dispatched several warning letters to firms that, according to the agency, have been making false claims about erectile dysfunction drugs. The following firms were cited: Access Financial, Bloomington, MN FDA objected to...

Concord Labs nets letter for faulty investigations.
August 1, 2006... A Feb. 23 through March 22, FDA investigation of the Concord Labs, Fairfield, NJ, the maker of colchicine tablets, hyoscyamine sulfate tablets and nitroglycerin sublingual tablets, documented deviations from current GMP regulations. ...

Sheffield cited for OOS, QC flaws.
August 1, 2006... An Oct. 17-19, 2005, inspection of Sheffield Labs, New London, CT, found significant deviations from FDA's current GMP regulations for finished pharmaceuticals. Significant deviations included failure of the QC unit to have adequate...

QS failures lead to warning letter for BioGenex.(Medical devices)
August 1, 2006... During an FDA investigation of BioGenex Labs, San Ramon, CA, conducted from Feb. 1 through March 9, the agency determined that the manufacturer of pathology related stains, antibodies and in vitro diagnostic test kits was not in conformance...

Cardiac Science cited for failure to control non-conforming products.
August 1, 2006... During an FDA investigation of Cardiac Science's Deerfield, WI-location, April 11-26, FDA determined the manufacturer of automated external defibrillators was not in conformance with the current GMP requirements of the QS regulation for medical...

Care Products slapped with letter for complaint procedures.
August 1, 2006... Between June 12 and 16, FDA investigators determined that Care Products, McAlflen TX, a manufacturer and distributor of shower gurneys/wheeled stretchers, shower chairs, manual mechanical walkers and chairs, and low resident (safety) beds, was...