Articles from Validation Times (August 1, 1999)

Title	Author	Type	Words
Aerscher owner ticked off at FDA validation desires.		Brief Article	361
Andersen bag-sealing, sterilization slapped.		Brief Article	406
Anspach hit on packaging, design validation, CAPA.		Brief Article	633
API company's cleaning, process validation faulted.		Brief Article	496
Baxter finds plane crash a snap, validation tougher.			881
Bird Life, Clarus cited for process validation faults.		Brief Article	323
Design validation faulted at Witt Biomedical cardiac site.		Brief Article	143
Firms advised to follow API guide for finished drugs.	Reid, Ken	Brief Article	1066
Full-scale or replica column validation needed, but don't over clean, FDA says.	Boyd, Kevin		535
Gel makers hit on SOPs, process validation errors.		Brief Article	306
Hi-Tech Pharmacal cleaning, chromatograms get warning.		Brief Article	328
Hoechst exec argues against arbitrary retesting intervals.	Dechnik, Peter	Brief Article	225
IVD maker protests FDA citations; agency is silent.		Brief Article	676
Medigloves' process change, CAPA procedures faulted.		Brief Article	390
Merger, validation slips converge at Novartis.		Brief Article	471
Only 9% of firms report failures to Atlanta region.	Karbarz, Mark	Brief Article	723
OOS procedures should be part of development phase.	Dechnik, Peter	Brief Article	732
OOS test assistance for generics seen in latest FDA comment.		Brief Article	470
Packaging cited at Becton, Mercury hit on calibration.		Brief Article	348
Prucka draws software, process validation letter.		Brief Article	313
Reuse of column resins raises inspector eyebrows.	Boyd, K.	Brief Article	351
Survey shows firms do up to 8 retests, don't use outliers.	Dechnik, Peter	Brief Article	529
Swiss fractionator gets hits on validation, no warning.		Brief Article	397
Validating process to strip viruses, 10% specs margin urged.	Boyd, Kevin	Brief Article	369
Warning Letter Analysis.	Field, Randi		26