Abstract
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.
- Received April 20, 1981.
- Accepted April 21, 1981.
- Copyright © Parenteral Drug Association. All rights reserved.
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