Articles from Validation Times (August 1, 2006)

Title	Author	Type	Words
23-item 483 for Allergy Labs citing aseptic processing, sanitation procedures, equipment cleaning.	Pickett, Joseph		993
Andrx Pharma on receiving end of 9-item 483 for OOS, QC violations, control procedures.	Pickett, Joseph		927
Big pharma to begin rollout of SAFE electronic sig system in 2007.	Pickett, Joseph		477
Cardiac Science cited for failure to control non-conforming products.			141
Care Products slapped with letter for complaint procedures.			479
Concord Labs nets letter for faulty investigations.			363
Lack of acceptance criteria and validation flaws nets 6-item 483 for American I.V.	Pickett, Joseph		592
Part 11 risk assessment 'not an alternative' to compliance with predicate rules.	Pickett, Joseph		713
Patient harm not key in prosecutions, U.S. attorney says.	Cezanne, Jeannette		673
Post-approval changes often unnecessary, continuous improvement could avoid them; guidance in offing.	Pickett, Joseph		434
QS failures lead to warning letter for BioGenex.			192
Several firms receive warning letters for questionable erectile dysfunction drug claims, including sildenafil.			985
Sheffield cited for OOS, QC flaws.			291
Technology seen as 'holy grail' in tracking products, improving product validation.	Cezanne, Jeannette		578
Validation plan should include risk prioritization of all company systems, says Acambis quality exec.	Pickett, Joseph		484