Articles from Validation Times (January 1, 2008)

Title	Author	Type	Words
5-item 483 given to Sunoptic for unvalidated processes.			625
ADE inspections drop from fiscal '06, but 150+ ADE inspections expected in FY 2008: Krueger.	Pickett, Joseph		549
ERA in EU required for previously registered APIs, but negative result doesn't mean marketing authorization denial.	Pickett, Joseph		576
Extractable/ leachable 483 observations focus on inadequate studies of leaching phenomena.	Pickett, Joe		771
ICH Q7 and EMEA documents establish some guidelines for leachables and extractables.	Pickett, Joe		515
Leaching can be avoided with appropriate, effective packaging systems.	Pickett, Joe		618
Life Care Technologies cited for flawed software validation.	Pickett, Joe		1101
Superior fails to establish procedures for non-conforming product.	Mashaw, Rebecca		314
Systematic process should be in place for leachable safety assessment: OPS.	Pickett, Joe		499
Warning letter cites CAPAs, complaints.	Mashaw, Rebecca		615