An essential component of good pharmacy practice is the correct storage and monitoring of refrigeration to ensure that temperature-sensitive therapeutic goods are continuously stored between 2 and 8 degrees celsius.
QCPP compliant refrigerators
Consistent with Strive for 5 Guidelines, pharmacies must store temperature-sensitive therapeutic goods in a purpose-built refrigeration unit that is designed and constructed specifically for therapeutic goods. This includes purpose-built refrigeration units that are integrated within an automated dispensing system.
The QCPP Compliant Dispensary Refrigerator list outlines which refrigerators are deemed compliant under the QCPP requirements. This list has been expanded to include refrigerators that have been determined to be QCPP compliant, e.g. refrigerators that are on the Australian Register of Therapeutic Goods (ARTG) in addition to Cold Chain Testing Centre (CCTC) approved refrigerators.
Refrigerator maintenance certification
Pharmacies have a choice of which provider confirms the accuracy of the refrigerator temperature.
The following entities can certify dispensary refrigerators:
- The Cold Chain Testing Centre
- Some refrigerator manufacturers
- An Australian Refrigeration Council (ARC) licensed refrigerator technician.
A Cold Chain Certificate is valid for two years from the date of issue stated on the certificate. On a pharmacy's QCPP assessment day, the Cold Chain Certificate must be current in order to be accepted.
Strive for 5 Guidelines
The Australian Department of Health’s Strive for 5 Guidelines offer best practice information and guidance on the storage of temperature-sensitive therapeutic goods.
In most states and territories, if your pharmacy is providing a vaccination service, you are expected to adhere to Strive for 5 Guidelines. QCPP also recommends that you refer to your state or territory health department policy to understand your full requirements.
More information on temperature monitoring is available in the QC2020 Knowledge Hub under Domain 4 - Premises, Infrastructure and Stock.