SOP for Stability Study Report Preparation: General steps that can be followed:
1. Identify the objective of the stability study and the regulatory guidelines that need to be adhered to.
2. Collect and record all relevant information for the study such as the product name, lot number, manufacturing date, expiration date, storage conditions, and analytical methods used.
3. Conduct the stability study according to the predetermined stability protocols.
4. Collect stability data at predetermined time intervals and store the data in validated electronic systems.
5. Analyze the data obtained from the study and compare it with the predetermined acceptance criteria.
6. Prepare a stability study report that includes a summary of the data collected, the analytical methods used, and the results obtained.
7. Summarize the stability data in tables and graphs that are easy to understand.
8. Include a conclusion and recommendations based on the stability data collected.
9. Review the report to ensure that it meets the regulatory requirements and guidelines.
10. Submit the report to the appropriate regulatory agency or internal department for review and approval.
