Think of the validation state in a simple manner like driving a car. One first wants to make sure there are four wheels, they are properly inflated and that the vehicle has gas. That would be like a Component Qualification. Next the car should be operated at its extreme conditions, as fast as possible in the worst weather and then as slow as possible. This is equivalent to the Operational Qualification, operating at the extreme conditions. The final step would be to take the car for a nice long drive like one would normally operate a car. 65 MPH on a nice little road trip, this would be equivalent to the Performance Qualification, the car functions as expected in nominal conditions. One may not operate their car at the extremes, but it sure is good to know that if you did have to operate in those conditions, one would have a high degree of confidence that it is achievable.
A cold chain can be managed by a quality management system. It should be analyzed, measured, controlled, documented, and validated.
The overall approach to validation of a distribution process is by building more and more qualifications on top of each other to get to a validated state. This is done by executing a Component Qualification on the packaging components. Next, an Operational Qualification that demonstrates the process performs at the operational extremes. The final piece is the Performance Qualification that demonstrates that what happens in the real world is within the limits of what was demonstrated in the Operational Qualification limits.
PDA (Parenteral Drug Association) Technical Report #39 gives a rough summary of how the cold chain can be validated.
The PDA's Technical Report states that a Component Qualification is required to demonstrate that a component can be manufactured to the design criteria of that individual component. This was put into the document because the industry did not understand the principles of Validation; all Validation processes were specific to equipment and not auxiliary processes such as shipping/distribution.
What are your thoughts on Validation?
Vivian Berni, Senior Advisor, Optimisation
I am a science and technology explorer who is connecting the dots within the life sciences and health care sectors. Logistics and supply chain management are just some of the many variables that I consider daily. Within LifeConEx/DHL, I’m keeping tabs on industry trends while looking for ways to optimise my customers’ business. Prior to this, I was a driver of innovation who was responsible for project implementations affecting customer journey, branding and ideation. Email thoughts, tips and questions to firstname.lastname@example.org or follow me on Twitter @vivianberni.