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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.

FDA Investigating Out of Specification (OOS) results for Pharmaceutical Production
Internet:http://www.gmp-compliance.org/guidemgr/files/1-9-1.PDF
Origin/Publisher:Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
Content:Guideline issued by FDA (CDER) on the handling of out of specification analysis results, in particular also as regards the responsibility of the laboratory technician and the laboratory manager in case of out of specification results.
Document Type:Guidance for industry

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