RT Journal Article
SR Electronic
T1 Inspectional Guidelines for Sterile Bulk Antibiotics
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 447
OP 451
VO 34
IS 6
A1 Henry L. Avallone
YR 1980
UL http://journal.pda.org/content/34/6/447.abstract
AB The sterilization of antibiotic powders and subsequent processing prior to filling represents one of the more challenging operations in the pharmaceutical industry. The processing of sterile bulk antibiotic powders involves some aseptic processing procedures not generally utilized in the production of a parenteral dosage form. The general processing procedures associated with sterile bulk production are discussed. Examples pertaining to agency regulatory philosophy are given.