Enhancements to cold chain requirements

QCPP is pleased to announce greater flexibility to the cold chain requirements.

• The QCPP Compliant Refrigerator list has been expanded to include refrigerators that have not been Cold Chain Testing Centre (CCTC) approved but have been determined to be QCPP compliant, e.g. those listed on the Australian Register of Therapeutic Goods (ARTG).
• Pharmacies can now choose to obtain their refrigerator maintenance certification from the CCTC or through another approved service provider.

QCPP acknowledges that cold chain technology is evolving. We have implemented these enhancements to Element 5 based on an analysis of Remedial Review Requests, as well as feedback received from pharmacies, manufacturers and EY Assessors.

Element 5, Action 4 – QCPP Compliant Dispensary Refrigerator
QCPP expect that your pharmacy must store temperature sensitive medicines 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.

In addition to CCTC approved refrigerators, the QCPP Compliant Refrigerator list has been expanded to include refrigerators that have been approved to be QCPP compliant, e.g. refrigerators that are ARTG listed.

Element 5, Action 6 – Certification of the dispensary refrigerator from the Cold Chain Testing Centre
The current mandatory QCPP requirement is that the pharmacy must have certification of the dispensary refrigerator from the Cold Chain Testing Centre (NSW).

Since implementation of the revised fees from 1 July 2017, which included removal of the subsidy for the Cold Chain Testing Centre, QCPP committed to providing pharmacies with a choice of which provider confirms the accuracy of the refrigerator temperature. Since 1 July 2017 this has been managed through the Remedial Review Request process and the Interpretations and Rulings Panel.

Effective immediately (Monday 16 July 2018), QCPP will apply concessions on-site during assessment if the pharmacy choose to use a service provider other than CCTC and can confirm the accuracy of the refrigerator temperature through either:

• Evidence that accuracy has been confirmed through a service provided by the refrigerator manufacturer OR
• Evidence that accuracy has been confirmed through a service provided by an Australian Refrigeration Council (ARC) licenced refrigerator technician.

QCPP has worked closely with EY to ensure EY assessors are aware of this update. QCPP understands that the Cold Chain Testing Centre (NSW) will continue to offer fee-for-service dispensary refrigerator testing services.

The Knowledge Hub has also been updated to include this interpretation.

Strive for 5 Guidelines – best practice is twice daily manual monitoring
QCPP currently accredits pharmacies against the AS85000:2011 Standard which stipulates once daily monitoring. However, QCPP understands that, consistent with the Australian Government’s Strive for 5 Guidelines, best practice is twice daily manual monitoring.

Moreover, QCPP is aware that in most states and territories, if your pharmacy is providing a vaccination service, you are expected to adhere to Strive for 5 Guidelines. QCPP recommends that you refer to your state or territory health department policy to understand your full requirements.

Use of data loggers
QCPP understands that technology for cold chain refrigeration is evolving, including the use of in-built or add-on automated continuous temperature monitoring systems, e.g. data loggers. Consistent with Strive for 5 Guidelines, pharmacies must continue to record minimum and maximum temperatures daily, regardless if a data logger is being used (please refer to the Strive for 5 Guidelines).

For further information on QCPP cold chain requirements, please visit the QCPP Knowledge Hub or call the QCPP Helpline on 1300 363 340.

June 2018 QCPP statistics

Number of QCPP assessments completed in June:
NSW:84  VIC:35  QLD:41  SA:10  ACT:6  WA:11  TAS:10  NT:2  Australia-wide: 193

Percentage of pharmacies currently QCPP accredited:
NSW:94.58%  VIC:91.3%  QLD:94.46%  SA:97.53%  ACT:98.68%  WA:94.98%  TAS:95.95%  NT:94.87%  Australia-wide:94.15% 

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