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