It is now approaching 2 years since the Chinese FDA began a push to adopt their proposal for regulations around Good Supply Practices (GSP) within China.
Although these regulations closely mirrored the EU GDP guidelines, and were focused on a ‘risk approach’ to managing quality, the expectation is for full adherence of these new regulations by the end of 2015.
This is a major task based upon many factors, including:
- A fragmented and complex supply chain, due to the vast and remote areas that exist.
- Challenges in shipping and packaging consolidation, due to regional weather conditions.
- Variations in previously established regional regulations which may or may not line up with the new GSP regulations.
All 3 of these factors pose potential implementation and harmonization issues for the new GSP rules, making the final adopted approach speculative at best.
Adherence to regulations like this is now becoming a global scale challenge, with the EU rules and varying rules in other Asia/Pacific countries, the Arabian Peninsula, South and Central America, and Canada (which has their own legislation related to cold chain and the transport of temperature sensitive drugs).
The ICH and other globally-focused organizations are working to introduce a more consolidated form of regulations for the management of drug quality related to cold chain distribution. However, this is a long-term vision, and in the meantime, more and more local regulations, like the CFDA GSP, are frequently being introduced, or updated.
So, as someone that needs to be compliant and feel that they have a good handle on GDP, GSP or general quality management of cold chain products, including vaccines, what are the key points of focus that will potentially be in all future initiatives?
From this writer's point of view, I see these as the following:
- Validated and profiled packaging for cold chain products to ensure that the products remain within the 2C to 8C range, or within the manufacturer’s recommendations for stability and efficacy maintenance. Also, storage facilities should meet the same criteria.
- The use of temperature monitoring devices for all shipments, including the installation of these devices or systems within warehouses and storage facilities, plus transportation vehicles, with alarm indications if the temperature falls outside of the recommended range.
- Development of a risk mitigation plan. A regular risk assessment review of your transportation systems to see if errors or unusual conditions are occurring at any points along the routes.
- Staff training - and retraining - as most supply chain errors are human errors. This should be coupled with good documentation to show what occurred, and good records of all and any trips (with or without) excursions.
- Reviews of all existing transportation and outsourced vendor services agreements, ensuring new regulations are met for: mode of transport, temperature monitoring throughout the supply chain, validated packaging, and consistency in temperature management and monitoring practices.
Always be prepared for the worst situations by having risk mitigation plans in place. Finally, remember to check the number of hand-off points in your supply chain where human intervention occurs, as this is where the best made plans can go wrong.