RT Journal Article
SR Electronic
T1 The Parenteral Drug Industry: Recent Findings
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 55
OP 58
VO 36
IS 2
A1 Fry, Edmund M.
YR 1982
UL http://journal.pda.org/content/36/2/55.abstract
AB FDA observes a wide variety of conditions at small volume parenteral manufacturers, and finds that many important aspects of CGMP are not well understood. FDA’s experience in conducting inspections will be discussed, as well as the future of CGMP’s for parenteral products.