Standards › Standard 1 › Standard operating procedures (SOPs)
Standard operating procedure (SOP) · PHM-SOP-001 · Version 1.0 · Approved by the ASF Expert Committee
Supports: 1.9
At a glance
- Store medicines in the dedicated medicine fridge at the temperature on the product label.
- Read the fridge thermometer twice each working day and record it on PHM-FRM-001.
- If the temperature is out of range, quarantine the stock at once and tell the pharmacist.
- Never use quarantined medicine until the pharmacist releases it in writing.
- The pharmacist reviews the log every week and signs it.
- Stop and get help straight away if: the temperature is out of range and the pharmacist cannot be reached, or the fridge has failed with no working backup.
1. Purpose
To keep medicines and vaccines at the temperature their manufacturers require, so that they remain safe and effective, and to act at once when that temperature is not maintained [EC].
2. Scope
| Applies to | All staff who store, check, prepare, or supply medicines and vaccines |
| Locations | All medicine and vaccine storage at the facility, including ward fridges, clinic fridges, emergency kits and transport boxes |
| When | At all times; daily readings; on any fault; on delivery of stock |
| Does not apply to | Controlled medicines security, which is covered by PHM-FRM-002 and the controlled medicines SOP |
3. Definitions
| Term | Meaning |
|---|---|
| Storage temperature range | The range printed on the product label or the manufacturer’s information (for example 2 to 8 degrees C for many refrigerated products). The label governs. |
| Excursion | Any reading outside the storage range |
| Quarantine | Keeping stock separate, labelled “DO NOT USE”, until the pharmacist decides |
| Min-max thermometer | A thermometer that records the lowest and highest temperature since it was last reset |
4. Background
Many medicines and vaccines lose potency or safety if stored outside the required temperature. Temperature failures often go unnoticed because nobody checks the record. A daily reading and a fast response to an out-of-range reading are the controls.
This SOP is the method for criterion 1.9: the fridge temperature log (last 3 months) is the audit evidence. Controlled medicines are recorded separately (PHM-FRM-002).
5. Responsibilities
| Role | Responsibility | Competence |
|---|---|---|
| Pharmacist in charge | Owns the storage standard; reviews excursions; releases or destroys quarantined stock; signs the weekly review | Clinical pharmacy competence |
| Ward or department head | Makes sure readings are recorded twice daily and faults are reported | Trained in this SOP |
| Nurse or clinician who uses medicines | Checks the stock is stored correctly; reports any excursion or fault at once | Trained in storage rules |
| Facilities manager | Repairs faults; provides backup power or a backup fridge | Maintenance competence |
6. Materials and equipment
| Item | Requirement | Condition |
|---|---|---|
| Medicine fridge | Dedicated; no food or drink; temperature display or thermometer at the centre of the fridge, not at the door | Working; door seals intact |
| Thermometer (min-max or data logger) | Calibrated as the hospital schedule sets (EC); reset after each reading | Readings visible; battery working |
| Temperature log (PHM-FRM-001) | Current version; filled in at the same times each day | Available at the fridge |
| Backup fridge or cool box | Set up for the hospital fault plan (EC) | Checked monthly |
7. Safety
- Do not store food, drink or specimens in the medicine fridge.
- Do not put medicines in the fridge door or on the fridge floor, where temperatures vary.
- Wear gloves when handling stock from quarantine if the product is damaged or leaking.
8. Before you start
- Check the fridge is working and the thermometer shows a reading.
- Check the stock is stored by product, with the expiry date visible.
- Check the storage range for each product on the label, not from memory.
9. Procedure
Step 1. Store stock correctly.
- Place products on the shelf they are designated for. Keep them away from the back wall and the fan.
- Store the newest stock behind older stock (first expiry, first out).
- Keep the fridge door closed except when taking stock out. Do not overload.
Key point: Airflow and placement keep the temperature even. The door is the most common point of warming.
Step 2. Read the thermometer twice each working day.
- Read at the set times: morning and afternoon (EC).
- Record the reading on PHM-FRM-001 with time, reading and your initials.
- Reset the min-max thermometer after each reading, and record the minimum and maximum if it is used.
Key point: Two readings a day show the trend. A single reading can miss a failure that starts overnight.
Step 3. If the reading is within range, continue normally.
- Note the reading in the log.
- Take no further action.
Key point: Routine readings are as important as the response to a problem.
Step 4. If the reading is out of range, act at once.
- Do not use any stock from the fridge until the pharmacist has decided.
- Move the stock to the backup fridge if it is safe to do so, and check its temperature.
- Label the stock “DO NOT USE – QUARANTINE” with the time, reading and your name.
- Inform the pharmacist immediately, by phone if needed, and record the time you informed them.
Key point: The first hour matters. Do not wait for the next reading to act.
Step 5. Investigate the fault.
- Check the power, the door seal, the thermostat setting, and whether the fridge has been opened repeatedly.
- Inform the facilities manager with the fault description.
- Record the cause on PHM-FRM-001 and in the incident report if stock was affected.
Key point: Knowing the cause prevents the next failure. Record it while it is still clear.
Step 6. Decide on the quarantined stock.
- The pharmacist assesses each product against the manufacturer information and the time out of range.
- The pharmacist either releases the stock in writing, or marks it for destruction.
- Record the decision on PHM-FRM-001 and file the written release or destruction note.
Key point: No medicine is used after an excursion without a written decision. This is the control that protects patients.
Step 7. Review the log each week.
- The pharmacist reviews the week’s log, checks every day has two readings, checks any excursion has a decision, and signs.
- Report any missing readings to the ward head.
Key point: A signed weekly review is the proof that the daily readings are being checked.
10. Decision points
- If a reading is within the storage range, record it and continue.
- If a reading is out of range, quarantine the stock and inform the pharmacist at once.
- If the fridge has failed and no backup is available, the pharmacist arranges for the stock to be moved to a safe place within the range and tells the facilities manager.
11. Special situations
| Situation | Action |
|---|---|
| Vaccines | Follow the vaccine cold chain plan. Any excursion is reported to the immunisation lead and the pharmacist before any dose is given (EC). |
| Emergency kits and transport boxes | Check at the start of each shift or journey. Record in the same log (EC). |
| Power failure | Use the backup plan. Keep the doors shut. Read the temperature every hour until power returns (EC). |
| Stock delivered | Check the delivery temperature on arrival. Store at once. Record any delivery outside range. |
12. Escalation
- Any excursion goes to the pharmacist at once, and is reported through INC-POL-001 if stock was affected.
- If the pharmacist cannot be reached within one hour, the clinical director decides on quarantined stock.
13. Monitoring
| Measure | Target | Frequency | Owner | If not met |
|---|---|---|---|---|
| Days with two temperature readings recorded in the last 3 months | 100% | Monthly audit of the log | Pharmacist in charge | Re-training; ward review |
| Excursions with a documented pharmacist decision within the same shift | 100% | Monthly | Pharmacist in charge | Escalated to clinical director |
| Weekly review signed | 100% | Monthly | Pharmacist in charge | Re-training; escalation |
14. Records
| Record | Kept in | Retention |
|---|---|---|
| PHM-FRM-001 Fridge Temperature Log | Ward or pharmacy file | 3 months minimum on site, then archived for the period set by the facility’s records policy years |
| Quarantine and release or destruction notes | Pharmacy file | the period set by the facility’s records policy years |
| Incident report (INC-POL-001) | Incident log | the period set by the facility’s records policy years |
15. Training
- All staff who store or use medicines are trained in this SOP at induction and each year (EC).
- Staff are assessed by observation of the daily reading and the excursion response.
16. Related documents
| ID | Title | Use |
|---|---|---|
| PHM-FRM-001 | Fridge Temperature Log | Used in steps 2 to 6 |
| PHM-FRM-002 | Controlled Medicines Register | Controlled medicines are recorded separately |
| SOP-044 | Medicine and Product Check Procedure (generic) | Used before supplying medicines |
| SOP-058 | Product and Medicine Recall Procedure (generic) | Used if a batch is affected by an excursion |
17. Evidence
| Reference | Note |
|---|---|
| E-009 | ASF Expert Committee consensus. Storage ranges come from product labels. Reading times, calibration interval and backup plan are EC decisions to confirm against WHO or national cold chain guidance before approval. |
18. Change history
| Version | Date | What changed | Approval |
|---|---|---|---|
| 1.0 | the date of approval | Full procedure written; added storage rules, excursion response, pharmacist decision, weekly review and vaccine notes | Approved by the ASF Expert Committee |
E-learning for this document
- Medication Safety: Operating SOP-MED-01 End to End (T-08)
- Care & Treatment: Clinical Standards for Accreditation (H-04)
References
- Accréditation Sans Frontières (2026). ASF Expert Committee consensus on Standard 1. (E-009)