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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 8: Sterility Test General Chapter
Internet:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm085370.pdf
Origin/Publisher:FDA
Content:This annex is the result of the Q4B process for the Sterility Test General Chapter
Status:final