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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.
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| Reviewer Guidance: Validation of Chromatographic Methods, 1994 |
| Internet: | http://www.fda.gov/cder/guidance/cmc3.pdf |
| Origin/Publisher: | FDA Office of Enforcement, HFC-200, 5600 Fishers Lane, Rockville, MD 20857 |
| 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. |
| Document Type: | Reviewer Guidance |
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