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.
FDA Reviewer Guidance: Validation of Chromatographic Methods, 1994
Origin/Publisher:
FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM134409.pdf
Document Type:
Reviewer Guidance
Content:
This FDA Reviewer Guidance is specifically directed at those FDA officials who check the dossiers for a marketing authorisation and gives instructions on which requirements should be made to the validation of analytical chromatographic methods. It contains many details concerning the system suitability test.
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