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SOP-QC-003Version 5.0Effective 2025-10-20Owner: Quality ControlEffective

Laboratory Testing

Fictional document for the demonstration.

§4.1 Specification review

Every result is compared with its approved specification and system suitability criteria. A result within specification with passing system suitability is reported without further review.

§4.5 Out-of-specification results

An out-of-specification result starts a laboratory investigation immediately and the batch is held until the investigation concludes.