RT Journal Article
SR Electronic
T1 Systems Validation for Parenteral Clinical Drugs—Application to R&D and QC Laboratories
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 45
OP 51
VO 37
IS 2
A1 Tetzlaff, Ronald F.
YR 1983
UL http://journal.pda.org/content/37/2/45.abstract
AB 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.