Articles from Validation Times (February 1, 2000)

Title	Author	Type	Words
ALP passes inspection for blow-fill seals, but FDAer notes some validation faults. (Blood/Biologics).			499
Associates of Cape Cod tripped on LAL products. (Blood/Biologics).			420
Audit of sterilizer leads FDA to reprocessing firm. (Blood/Biologics).			762
Cleaning, sanitation issues threaten seizure at packer. (Blood/Biologics).			176
Clinical diagnostics hit for process validation. (Medical Devices).			608
FDAer cuts language barrier to nail computer validation. (Human Drugs).			599
FDAer suggests giving summary of media fill validation errors. (Media fills).	Reid, Ken		428
Genetics Institute nailed on water, utilities in team audit. (Blood/Biologics).			252
Guidance/Regulation Tracker.			2047
HVAC guide to give 'some wiggle room' on outside pressure. (Environmental monitoring).			260
Metuchen analytical got secure computer after EIR. (Human Drugs).			533
Mexican glove makers hit on validation, leak testing. (Blood/Biologics).			318
New 314.70 guide may allow CBE-30 for rapid methods. (Methods validation).			569
P&U N.J. plant cited for HEPA, HVAC problems. (Blood/Biologics).			345
Pertussis toxin validation is N. American Vaccine issue. (Blood/Biologics).			350
Roche validation summary provided for unvalidated, hybrid, drug manufacturing. (Blood/Biologics).			654
Stability, cleaning, RO water at issue with OTC topicals. (Blood/Biologics).			410
USP may do chapter on equivalency of micro methods; PDA 33 due by April. (Methods validation).			468
Validating labware without staff input faulted by FDAer. (Labs).	Dechnik, Peter		653