PT  - JOURNAL ARTICLE
AU  - Agalloco, James
TI  - The Validation Life Cycle
DP  - 1993 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 142--147
VI  - 47
IP  - 3
4099  - http://journal.pda.org/content/47/3/142.short
4100  - http://journal.pda.org/content/47/3/142.full
SO  - PDA J Pharm Sci Technol1993 May 01; 47
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.