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PHARMA DEVILS QUALITY CONTROL DEPARTMENTSTANDARD OPERATING PROCEDURE Department: Quality Control Title: Instrument Qualification SOP No.: Effective Date:Supersedes: Review Date: Page No.:Issue Date:
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Gather all necessary information and documentation related to the out-of-specification result.
02
Investigate the root cause of the out-of-specification result.
03
Develop a corrective and preventive action plan.
04
Document all actions taken in response to the out-of-specification result.
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Review and approve the SOP for handling out-of-specification results.

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SOP for handling of out-of-specification results is a standard operating procedure that outlines the steps to be taken when test results fall outside of established specifications.
All employees involved in testing and quality control are required to follow the SOP for handling of out-of-specification results.
The SOP should be filled out by following the outlined procedures and documenting any deviations or corrective actions taken.
The purpose of the SOP is to ensure that out-of-specification results are properly investigated, documented, and addressed to maintain product quality and safety.
The SOP should include details of the testing performed, the specific results that are out of specification, any potential reasons for the deviation, and the actions taken to address the issue.
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