Articles from Validation Times (July 1, 2002)

Title	Author	Type	Words
Cleaning validation expected to be complete by year's end, patched screens discontinued. (Human drugs).	Witkowski, Wallace		677
Ex-inspector identifies 6 areas FDA will examine in probing computer/software changes. (Change control/computers).			755
Fake drugs the norm in Eastern Europe, China; inspectors offer lessons to FDA, industry. (Counterfeiting).	Cassidy, Victor		518
FDA calls Iso-Tex sterility validation acceptable but stability and complaint handling lacking.			659
FDA questions Vintage Pharma's re-evaluation of products cited in response to 483. (Human Drugs).		Brief Article	206
FDA seeks to provide "clear explanation of expectations" with regard to stability data. (Stability).	Huegel, Kelly		673
FDA takes beating from both sides at committee hearing on re-importation; debate focuses on safety. (Counterfeiting/imports).	Huegel, Kelly		834
FDAer concerned about reworked/reprocessed starting materials for bulk drug substances. (Drug substances).	Cassidy, Victor		1038
Firm attributes quick 483 turnaround time to contract manufacturing volume. (Biologics).		Brief Article	752
In-house committee to review changes, sticking with change program advised by McNeil exec. (Change control).	Ludwig, Elisa		512
Industry part 11 group still seeks `interim' relief, commercial software usage, hybrid paper/electronic systems. (Electronic records/signatures).	Cassidy, Victor		1141
Kiel states unvalidated processes, HPLC 483 deficiencies resolved.			697
Vita-Erb warning letter prompts testing of OTC products.		Brief Article	195