1995_March.pdf

HUMAN DRUG CGMP NOTES (Volume 3, Number 1) March, 1995 (A Memo on Current Good Manufacturing Practice Issues on Human Use Pharmaceuticals) Issued By: The Division of Manufacturing and Product Quality, HFD-320 Office of Compliance Center for Drug Evaluation and Research Project Manager: Paul J. Motise, HFD-323 Addressee Database Manager: Russ Rutledge, HFD-323 IN THIS ISSUE: 2) Has the odor test been eliminated from the prefill inspections, due to Motises Notebook concerns over pathogenic contamination or other dangerous Policy Questions On: compounds? · What kinds of USP dissolution test Published In Final: failures are significant enough to be noted on Forms FD-483 ? · CGMP revisions; retrospective review, final rule, 1/20/95, effective · Is pressure sensitive labeling on a roll 2/21/95. considered to be cut labeling? · Would FDA disapprove a Toward The Electronic Government: pharmaceutical plant because it was located next to a landfill site? · Human Drug CGMP Notes; 1995 Cumulative issues to be posted to · Is it acceptable for two employees to Internet FTP server. verify correctness of hand applied labeling inserts by inspecting the Focus On: Media Fill Contamination Rate insert bar codes or bleed lines (for correct alignment)? Attachments: · Gas What? (Policy Questions on Medical Gases): Division of Manufacturing and Product Quality, HFD-320 Subject Contacts 1) What is the significance of the air liquefaction statement? Is further FAX FEEDBACK testing required if this statement is (Your input requested) not available? MOTISES NOTEBOOK: HUMAN DRUG CGMP NOTES March, 1995 Welcome to another edition of Human Drug CGMP Notes, our periodic memo on CGMP for human use pharmaceuticals. This begins our third year. Your FAX FEEDBACK responses are still excellent and we especially appreciate your suggested topics for coverage. Weve revised FAX FEEDBACK to enable us to better respond to your particular questions o