Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.
| Author/creator | International Conference on Harmonisation |
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | [Rockville, Md.?] : [U.S. Food and Drug Administration, Center for Biologics Evaluation and Research] |
| Description | 10 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS110458 |
| Subjects |
| Portion of title | ICH regions on Sterility Test General Chapter |
| Cover title | Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions |
| General note | Title from PDF title page (viewed on Mar. 20, 2009). |
| General note | "Current step 2 version 1, dated 13 November 2008." |
| General note | "Draft consensus guideline." |
| General note | "Q4B annex 8." |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 2). |
| Technical details | Mode of access: Internet at the FDA Web site. Address as of 3/20/09: http://www.fda.gov/cder/guidance/8668dft.pdf ; current access is available via PURL. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:P 49/4 |