Guidance for industry : sterile drug products produced by aseptic processing, current good manufacturing practice.

Other author Center for Drug Evaluation and Research (U.S.)
Other author Center for Biologics Evaluation and Research (U.S.)
Other author United States. Food and Drug Administration. Office of Regulatory Affairs.
Format Electronic
Publication InfoRockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]
Description1 online resource (59 p.)
Supplemental Contenthttps://purl.fdlp.gov/GPO/LPS116640
Subjects

Portion of title Sterile drug products produced by aseptic processing, current good manufacturing practice
General note"Center for Biologics Evaluation and Research (CBER)."
General note"Office of Regulatory Affairs (ORA)."
General note"Pharmaceutical CGMPs."
General note"September 2004."
General noteGPO Cataloging Record Distribution Program (CRDP).
Bibliography noteIncludes bibliographical references (p. 54-55).
GPO item number0499-T (online)
Govt. docs number HE 20.4702:ST 3

Availability

Library Location Call Number Status Item Actions
Electronic Resources Access Content Online ✔ Available