Compliance and Risk Management

The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.

Although I have written a few times about the importance of compliance I am taking this opportunity to reiterate with the introduction of these newest recommendations that the FDA is beginning to use as audit references, following the rules is more important than ever.

So as a life sciences company 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?

As stated previously, from this writer's point of view I see these as the following:

1. Validated and profiled packaging for cold chain products to insure that the products remain within the 2C to 8C range or within the manufacturers recommendations for stability and efficacy maintenance. Also storage facilities should meet the same criteria.
2. 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. Countries like Saudi Arabia are now going to require a data logger per shipment with an LCD display to indicate current and all trip temperature data.
3. A regular risk assessment review of your transportation systems to see if errors or unusual conditions are occurring at any points along the routes and setting in place a risk mitigation plan.
4. Staff training and retraining as most supply chain errors are humanly created. This should be coupled with good documentation to show that this occurred and good records of all and any trips with, or without, excursions.
5. Review all existing transportation and outsourced vendor services agreements to insure that they meet the new regulations for mode of transport, temperature monitoring throughout the supply chain, validated packaging, and consistency in the their temperature management and monitoring practices.
6. A regular review process for your suppliers with established audit procedures and a risk assessment review check list.
7. A CAPA plan detailing the process from start to finish as this type of documentation and reporting is critical to show compliance is being maintained.

Always be prepared for the worse situations and plan for these so that you are prepared and have 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 and usually go wrong.