Articles from Validation Times (April 1, 2002)

Title	Author	Type	Words
FDA may rewrite compounding rules 'from scratch'.	Huegel, Kelly	Brief Article	475
Firms should move to process analytical technology, top CDER official says.	Huegel, Kelly	Brief Article	445
GOJO hopes to clean up remaining validation deficiencies by 2003.		Brief Article	277
Holox hit for unvalidated USP assays, GC suitability.		Brief Article	606
JOAMCA cleaning, installation validation doesn't wash with FDA.(JOAMCA Chemical Products, Food and Drug Administration).		Brief Article	484
Lax calibration, MDR of chiropractic table pinned on Sweat.		Brief Article	314
Merck's West Point 483 replete with aseptic deficiencies.		Brief Article	722
Not all equipment can be validated as Part 11 'compliant'; distinguishing critical/non-critical data important.	Seeley, Robert	Brief Article	416
Organization of data rates high with FDA, along with security.	Ludwig, Elisa	Brief Article	720
Scope, intensity of investigations should be dictated by type, source of adverse information.	Huegel, Kelly	Brief Article	880
Six of 30 Cumberland Swan GMP violations date back two years: FDA.		Brief Article	379
Summary points regarding GMP investigations.		Brief Article	46
Tyco told to reign in questionable sterility validation at Radionics.		Brief Article	382
Undocumented design change could have Dayton in hot water.		Brief Article	350
Use of common equipment in tissue-based products concerns FDA; cellular, tissue rules designed to be risk-based.	Huegel, Kelly	Brief Article	510
Veterinary drug maker Phoenix held to human drug GMPs.		Brief Article	531
Virus filter validation testing on bacteriophages O.K., despite FDA guidance: Pall exec.	Seeley, Robert	Brief Article	499