When we perform a scientific study through a study protocol and get a conclusion, the conclusion of that protocol can becomes a part of SOP with reference of that protocol. If yes so please provide any reference no. Or part as per any regularly
Please understand the difference between the study protocol and the study report.
A protocol is a “Plan” describing in sufficient detail how the study/validation work will be done, who will do it, what will be done, how to document the results, etc.
The study report is meant to record the study/validation results, observations, study/validation outcome and conclusion, etc. when the study/validation work is conducted according to the protocol.
Therefore, the conclusion of a study should be recorded in the study report.
SOP is a document that has procedural instructions to be followed to perform a specific task or activity. Hence, the “Conclusion” of the study has no relevance to the SOP. The conclusion of the study usually states whether the conducted study met the acceptance criteria as defined in the study protocol. For example, in a process validation study report, the “Conclusion” can be whether the process validation results obtained met the acceptance criteria as defined in the PV protocol and whether the process validation was successful (the process is valid). Based on the conclusion of process validation study the Master Batch Mfg. (MBR) document should be finalized and then Batch Mfg. Record (BMR) contents should be generated and followed for the manufacturing of that product batches.
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