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FDA Guidance for Industry: Investigating Out of Specification (OOS) results for Pharmaceutical Production

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

Document Type:
Guidance for industry
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.

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