PT  - JOURNAL ARTICLE
AU  - Clifford G. Broker
TI  - Validation in Perspective- 1981
DP  - 1981 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 167--169
VI  - 35
IP  - 4
4099  - http://journal.pda.org/content/35/4/167.short
4100  - http://journal.pda.org/content/35/4/167.full
SO  - PDA J Pharm Sci Technol1981 Jul 01; 35
AB  - The presentation provides a retrospection of significant events since early 1976—statements from key officials, and publications by technical groups—contributing toward the current regulatory and industrial achievements in balancing validated processes, in-process controls, and end-product testing in a basic drug product quality equation. Current and future concepts of validation are discussed as they relate to the primary drug product manufacturer and to others, such as the contract sterilizer and aseptic filter manufacturer. Discussion includes an analysis of the potential for publishing validation documents as either guidelines or regulations.