Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products.
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008] |
| Description | i, 12 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS111982 |
| Subjects |
| Portion of title | Validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products |
| General note | Title from PDF title page (viewed on Apr. 28, 2009). |
| General note | "Draft guidance". |
| General note | "February 2008". |
| General note | Includes bibliographical references (p. 12). |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Technical details | Mode of access: Internet at the FDA CBER Web site. Address as of 4/28/09: http://connexion.oclc.org/WebZ/CorcSCAN?sessionid=cnxs04.prod.oclc.org-38204-fu2vwnqz-d2g4oh ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:R 18 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |