Abstract
The production of parenteral products for clinical use represents unique burdens and problems for quality control and research and development laboratories involved in product development. Since the application of GMP’s to QC and R&D laboratory operations is frequently the subject of controversy. this presentation attempts to discuss the FDA position on this matter. While the FDA does consider that GMP’s do apply to QC and R&D laboratories involved in clinical drug development, it is recognized that there are legitimate questions about which systems need to be validated and to what degree. The rationale or need for validation is emphasized, and recent FDA experiences are utilized to illustrate problem areas. Finally, some R&D and QC systems for which validation should be considered/required are identified.
- Received August 12, 1982.
- Accepted December 12, 1982.
- Copyright © Parenteral Drug Association. All rights reserved.
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