Articles from Validation Times (December 1, 2004)

Title	Author	Type	Words
2-item 483 to Cardinal Health cites lack of lab determination of conformance to final specs, OOS.			420
Agency cites Blood Net for equipment maintenance, calibration faults.	Heitman, Evelyn		332
American Diagnostica lyophilization process not validated.	Heitman, Evelyn		288
Boehringer Ingelheim Vetmedica lacks sampling, testing to validate performance.	Heitman, Evelyn		342
CHPA guideline on OTC drug stability testing still under development.	Seeley, Robert; Reid, Ken		255
Computerized Radiation Scanners lacks procedures for validating device design.	Heitman, Evelyn		196
FDA background document on follow-on 'protein pharmaceuticals' seen by January, draft guidance to follow in early spring.	Pickett, Joseph		890
Germiphene process validation inadequate.	Heitman, Evelyn		337
IVD maker slapped with 4-item 483 for failing to validate processes, document validation activities.			544
Lowlyn Pharmacies found compounding outside VCPR.	Heitman, Evelyn		300
Mammalian cell technology improving, expert notes; 1-4g/L realized now, 5-10g/L expected soon.	Pickett, Joseph		561
Multidisciplinary approaches, pared down SOPs can simplify network qualification.	Ludwig, Elisa		692
Process, software validation CAPA faults cited at Clarity.	Heitman, Evelyn		477
Shin Chang Medical lacks validation for sterilization, CAPA.	Heitman, Evelyn		429
Taiwan API maker gets 12-item 483 for validation, OOS, calibration violations.			524
Training IT personnel, improving documentation are critical for compliant networks.	Ludwig, Elisa		1112