As per FDA requirement a Lab investigation must be conducted whenever an Out-of- Specification (OOS) result is observed. This SOP defines the Requirements for dealing with failed test results.
Upon completion of the analysis the analyst checks the results for Specifications. The tests should be carried out by two different analysts in duplicate.
Investigation reports should include: steps taken, raw data, supporting documents, findings and explanations, conclusions and recommendations to avoid occurrence of similar deviations in the laboratory. ( not included as part of this SOP as these are separate documents and SOP only defines the process)
Product ID : KTCP241
Format: Editable Word document
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