Procedure for Conducting Freeze Thaw Studies
Purpose
The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for conducting freeze thaw studies. These studies are conducted to evaluate the stability of pharmaceutical products when subjected to cycles of freezing and thawing.
Scope
This SOP applies to all pharmaceutical products undergoing freeze thaw stability testing within the facility.
Responsibilities
- Stability Manager: Oversee the freeze thaw study process and ensure compliance with this SOP.
- Laboratory Technicians: Conduct freeze thaw cycles, perform testing, and document results.
- Quality Assurance (QA) Team: Review and approve freeze thaw study records and reports.
Procedure
- Preparation:
- Select the samples for freeze thaw studies according to the
study protocol.
Ensure that the samples are properly labeled and documented.
Gather necessary equipment, including freezers and temperature monitoring devices.
Verify the calibration status of temperature monitoring devices and freezers.
Freeze Thaw Cycles:
Post-Cycle Testing:
Documentation:
Maintenance:
Record Keeping:
- Place the samples in the freezer set at the specified temperature (e.g., -20°C) for the designated time period (e.g., 24 hours).
- After the freezing period, remove the samples and allow them to thaw at room temperature for a specified period (e.g., 24 hours).
- Repeat the freeze thaw cycles as per the study protocol (e.g., three cycles).
- Monitor and record the temperature during each cycle to ensure compliance with the specified conditions.
- After the final thaw cycle, perform the required tests on the samples to assess stability (e.g., assay, degradation products).
- Document all test results in the study records.
- Compare the results with pre-established acceptance criteria to determine stability.
- Record all freeze thaw cycles, temperature data, and test results in the study records.
- Ensure all data entries are complete, accurate, and signed by the personnel performing the study.
- Submit the study records to the Stability Manager and QA Team for review and approval.
- Perform regular maintenance of the freezers and temperature monitoring devices according to the manufacturer’s recommendations.
- Calibrate the temperature monitoring devices periodically to ensure accuracy.
- Keep maintenance and calibration records up-to-date and accessible for review.
- Maintain all study records, including temperature logs and test results, in a centralized location for easy access and review.
- Ensure electronic data is backed up regularly and securely stored.
- Archive records according to the facility’s document retention policy and regulatory requirements.
Abbreviations Used
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Study Records
- Temperature Logs
- Test Results
References
- Study Protocol
- Manufacturer’s Guidelines for Freezers and Temperature Monitoring Devices
SOP Version
Version 1.0 – Effective Date: [Insert Date]