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Practices, and agree on an acceptable analytical practice (AAP) ..... form the method. ... Guidance for Industry, Investigating Out of Specification (LOS) Test.
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What is investigation of out-of-specification results?
Investigation of out-of-specification results is the process of determining the root cause of results that do not meet the specified requirements or standards.
Who is required to file investigation of out-of-specification results?
It is usually the responsibility of the quality control department or the quality assurance department to file investigation of out-of-specification results.
How to fill out investigation of out-of-specification results?
The investigation should be filled out following the specific guidelines and procedures set by the company or regulatory authorities, including documenting all findings and conclusions.
What is the purpose of investigation of out-of-specification results?
The purpose of the investigation is to identify the cause of the out-of-specification results, implement corrective actions, and prevent recurrence in the future.
What information must be reported on investigation of out-of-specification results?
The investigation report should include details of the testing procedure, deviations from specifications, root cause analysis, corrective actions taken, and any follow-up actions.
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