Standard Operating Procedure (SOP)

1. Purpose

To ensure the safe storage, handling, and monitoring of temperature-sensitive medicines, maintaining their quality, efficacy, and safety at all times.

2. Scope

This policy applies to all staff involved in the receipt, storage, monitoring, and management of refrigerated medicines within the service.

3. Definitions

• Cold Chain: The system of transporting and storing medicines within the recommended temperature range of 2–8°C from manufacture to administration.

• Temperature Excursion: Any deviation outside the recommended temperature range.

4. Responsibilities

• Clinical Lead: Overall accountability for cold-chain compliance.

• Practice / Service Manager: Ensuring systems, equipment, and audits are in place.

• Clinical Staff: Daily monitoring, documentation, and escalation of issues.

• All Staff: Reporting incidents or concerns immediately.

5. Equipment Requirements

• Dedicated medicines refrigerator (not used for food or specimens)

• Lockable or located in a restricted-access area

• Calibrated digital minimum/maximum thermometer or data logger

• Clear labelling: “Medicines Only”

6. Storage Requirements

• Refrigerated medicines must be stored between 2–8°C at all times

• Medicines must be stored in original packaging where possible

• Do not overcrowd the refrigerator; allow air circulation

• Medicines must not be stored in fridge doors or directly against cooling elements

7. Receipt of Refrigerated Medicines

• Deliveries must be checked immediately on arrival

• Confirm medicines are cool to touch and packaging intact

• Record delivery date and place medicines into the refrigerator without delay

• Any concerns must be escalated before medicines are used

8. Temperature Monitoring

• Refrigerator temperatures must be checked and recorded daily (including weekends if applicable)

• Record current, minimum, and maximum temperatures

• Reset min/max thermometer after recording

• Records must be retained for audit purposes

9. Temperature Excursions

If the temperature falls outside 2–8°C:

• Quarantine affected medicines immediately (label “Do Not Use”)

• Do not discard unless advised

• Record details of the excursion (temperature, duration, medicines affected)

• Seek advice from pharmacy/manufacturer

• Document outcome and actions taken

• Complete an incident report if required

10. Power Failure or Equipment Failure

• Escalate immediately to the manager or clinical lead

• Keep refrigerator door closed if safe to do so

• Transfer medicines to contingency storage if available

• Document the incident and actions taken

• Arrange urgent repair or replacement of equipment

11. Cleaning and Maintenance

• Refrigerator cleaned regularly according to local cleaning schedules

• Cleaning must be documented

• Annual calibration and servicing of temperature monitoring equipment

12. Training and Competency

• Staff handling refrigerated medicines must receive cold-chain training

• Competency must be assessed and refreshed regularly

• Training records must be maintained

13. Audit and Review

• Regular audits of temperature records and compliance

• Policy reviewed annually or following incidents or regulatory change

Document Control

Approved by:Caroline Balazs
Role: Lead Clinical Prescriber
Date: 01/01/2026
Review Date: 01/01/2027
Version: 1.0

Associated Documents:

• Medicines Management SOP

• Incident Reporting Policy

• Prescribing Policy

Done ✅