Systems validation for parenteral clinical drugs--application to R&D and QC laboratories
Tetzlaff, R.F.
Journal of Parenteral Science and Technology a Publication of the Parenteral Drug Association 37(2): 45-50
1983
ISSN/ISBN: 0279-7976 PMID: 6345744 Document Number: 219541
The production of parenteral products for clinical use represents unique burdens and problems for quality control [QC] and research and development laboratories [R and D] involved in product development. Since the application of GMP [Good Manufacturing Practices] to QC and R and D laboratory operations is frequently the subject of controversy, this presentation attempts to discuss the FDA [USA Food and Drug Administration] position on this matter. While the FDA does consider that GMP do apply to QC and R and 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. Some R and D and QC systems for which validation should be considered/required are identified.