Standard Operating ProcedurePharmaceuticalSOP-QC-003

Investigation of Out-of-Specification Results

What to do when a test result is outside its limit: the laboratory check first, then the full investigation, retesting rules and the batch decision.

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Sections: Purpose, Scope, Responsibilities, Definitions, Procedure, Records, References
16 numbered steps, written to GMP principles
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This document is a starting point written to GMP principles. Before use, check it against your own site, products and regulatory requirements, and approve it through your own quality system.