Experience with validation of clinical trial materials: an inspector's viewpoint.
The new EU directive now states quite clearly that GMP applies to Clinical Trials Manufacturers and implicit in this is process validation. Although it is generally accepted that full process validation may not be possible at Clinical Trails, there are many areas which can and should be validated, and certainly when a product is administered to patients. It is also noteworthy that Annex 13 is currently being revised and this has implications with regard to validation, especially of equipment and facilities.
Wolfe
L
L
Irish Medicines Board, Earlsfort Terrace, Dublin, Republic of Ireland. Linda.wolfe@imb.ie
D000818:Animals; D001688:Biological Products / Q000592:standards*; D001709:Biotechnology / Q000379:methods; D002845:Chromatography / Q000295:instrumentation / Q000379:methods; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence* / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D015507:Drugs, Investigational / Q000592:standards*; D005060:Europe; D033161:Government Regulation; D006801:Humans; D011786:Quality Control; D015203:Reproducibility of Results
D001688:Biological Products; D015507:Drugs, Investigational