Standard Operating Procedure for Stability Study Storage Condition Monitoring

Purpose

The purpose of this SOP is to establish procedures for the monitoring and control of storage conditions during stability studies in the pharmaceutical industry.

Scope

This SOP applies to all personnel involved in the storage and monitoring of pharmaceutical products undergoing stability studies.

Responsibilities

• Quality Assurance: Responsible for overall oversight and approval of the storage condition monitoring process.
• Quality Control: Responsible for routine monitoring of storage conditions and reporting any deviations.
• Facility Management: Responsible for maintaining stability chambers and storage units.

Procedure

1. Ensure that stability chambers and storage units are appropriately qualified and calibrated.
2. Monitor and record storage conditions regularly, including temperature, humidity, and any other relevant parameters specified in the study protocol.
3. Place calibrated monitoring devices (e.g., data loggers) in strategic locations within stability chambers to ensure uniform conditions.
4. Implement an alarm system to notify personnel of any deviations from specified storage conditions.
5. Investigate and document any deviations from the specified storage conditions promptly. Take corrective actions as necessary.
6. Review and trend data to identify patterns and potential issues with storage conditions.
7. Document any changes in storage conditions due to maintenance activities and ensure that these changes are within acceptable limits.
8. Regularly review and update the monitoring schedule based on the requirements of the stability study.

Abbreviations

No abbreviations