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Out of Specification Investigation SOP Example-Template
This SOP Example–Template defines the policy and procedure for the investigation, documentation and handling of known laboratory errors and discrepant (out-of-specification and atypical) laboratory test data/results which should be performed by your department personnel. The procedure si applicable to analytical research and development personnel, in-process analysts, quality control chemists, and any other personnel who are involved in CGMP analysis of clinical-phase or commercial products. This SOP Example – Template is a modifiable 51 page Microsoft® Word document. This product is available for download.