Standard Operating Procedure for Refrigerator for Drug Storage

1) Purpose

The purpose of this SOP is to provide guidelines for the operation, monitoring, and maintenance of refrigerators used for the storage of drugs, particularly ocular dosage forms, in the pharmaceutical manufacturing facility.

2) Scope

This SOP applies to all refrigerators used for storing ocular dosage forms and other temperature-sensitive pharmaceutical products within the facility, ensuring that they are kept within the specified temperature range to maintain product integrity and efficacy.

3) Responsibilities

The responsibilities include the operation, monitoring, and maintenance of the refrigerators. Facility staff are responsible for following this procedure, and the maintenance team is responsible for regular checks and calibration.

4) Procedure

4.1 Start-Up Procedure

1. Ensure the refrigerator is clean and free from any previous samples or contaminants.
2. Verify that the refrigerator is set to the specified temperature range (typically 2-8°C for ocular dosage forms).
3. Place a calibrated thermometer inside the refrigerator to monitor the temperature.

4.2 Operation

1. Store drugs in the refrigerator as per storage requirements, ensuring they are properly labeled and organized.
2. Monitor and record the temperature of the refrigerator at least twice daily (morning and evening).
3. Ensure the door is closed properly after each use to maintain the internal temperature.
4. Take immediate corrective actions if the temperature deviates from the specified range.

4.3 Maintenance

1. Perform regular cleaning of the refrigerator, including the removal of expired or unused drugs.
2. Check and clean the door seals regularly to ensure proper closure.
3. Schedule periodic maintenance and calibration of the refrigerator as per the manufacturer’s recommendations.
4. Document all maintenance and calibration activities in the logbook.

4.4 Shutdown Procedure

1. If the refrigerator needs to be taken out of service, remove all drugs and transfer them to an alternative storage location maintaining the required temperature.
2. Clean and disinfect the interior of the refrigerator.
3. Unplug the refrigerator and leave the door slightly open to prevent mold growth.

5) Abbreviations, if any

None

6) Documents, if any

1. Temperature monitoring logbook
2. Maintenance records
3. Calibration certificates

7) Reference, if any

GMP Guidelines for the storage of pharmaceutical products.

8) SOP Version

Version 1.0