RT Journal Article
SR Electronic
T1 The Validation Life Cycle
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 142
OP 147
VO 47
IS 3
A1 Agalloco, James
YR 1993
UL http://journal.pda.org/content/47/3/142.abstract
AB The Validation Life Cycle is an implementation mechanism which can assist pharmaceutical (and other types of medical product) manufacturers in the organization and execution of validation activities. A considerable body of work exists which identifies how to validate processes of various type and description. Unfortunately, there is a paucity of information on how to organize these individual validation activities into a cohesive whole. This paper describes a suggested means for achieving an organization’s validation goals in a rational and effective fashion. To best understand the advantages of a life cycle for validation, a recap of the history of validation in the U.S. pharmaceutical industry is useful.