Standard Operating Procedure for Cold Room for Raw Material Storage

1) Purpose

The purpose of this SOP is to provide guidelines for the operation, monitoring, and maintenance of the cold room used for the storage of raw materials, particularly those used in the manufacturing of ocular dosage forms, in the pharmaceutical manufacturing facility.

2) Scope

This SOP applies to all cold rooms used for storing raw materials that require controlled low-temperature environments to maintain their quality and efficacy within the pharmaceutical manufacturing facility.

3) Responsibilities

The responsibilities include the operation, monitoring, and maintenance of the cold room. 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 cold room is clean and free from any previous contaminants.
2. Verify that the cold room is set to the specified temperature range (typically 2-8°C or as required by the raw materials).
3. Place calibrated thermometers or temperature sensors inside the cold room to monitor the temperature.

4.2 Operation

1. Store raw materials in the cold room as per storage requirements, ensuring they are properly labeled and organized.
2. Monitor and record the temperature of the cold room at least twice daily (morning and evening).
3. Ensure the cold room 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 cold room, including the removal of expired or unused materials.
2. Check and clean the door seals regularly to ensure proper closure.
3. Schedule periodic maintenance and calibration of the cold room’s temperature control systems as per the manufacturer’s recommendations.
4. Document all maintenance and calibration activities in the logbook.

4.4 Shutdown Procedure

1. If the cold room needs to be taken out of service, remove all raw materials and transfer them to an alternative storage location maintaining the required temperature.
2. Clean and disinfect the interior of the cold room.
3. Turn off the cold room 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 raw materials.

8) SOP Version

Version 1.0