RT Journal Article
SR Electronic
T1 Validation in Perspective- 1981
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 167
OP 169
VO 35
IS 4
A1 Clifford G. Broker
YR 1981
UL http://journal.pda.org/content/35/4/167.abstract
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.