Written by Modality Solutions
Posted on: September 5, 2017
Part three of a four part post focuses on the Operational Qualification (OQ) portion of the transport validation process. As discussed in Part Two, conducting a component qualification (CQ) and installation qualification, gives us a well-defined specification of system operational capability and tolerances. OQ plays a critical role in the transport validation process by testing critical parameters of the system/process at expected extremes while confirming that the process is adequate to deliver unadulterated products. It is important to conduct OQ tests in a laboratory to ensure that the product is exposed to the expected extremes within the design space of the transport environment. Testing the ‘edges’ of your design space is critical to meeting expectations of the FDA and their ‘Quality by Design’ initiatives. You can’t guarantee that by shipping product in actual ‘real world’ transport conditions will test your design space. You may not get exposures to desired extreme transport conditions for temperature, pressure, shock/vibration and humidity at one time let alone concurrently!
OQ testing should be conducted using GMP-manufactured product in its final or market formulation or be as close to it as possible. This GMP final formulation includes having the drug product in a qualified primary packaging, which is then placed in a representative qualified secondary packaging along with all the labels. This drug product package should be placed in a qualified insulated shipper container which must be packed as per a well-defined standard operating procedure for pack-out instructions. All materials must be properly pre-conditioned prior to packing and the packing process should try to replicate the real-life scenario as close as possible. Ensuring proper handling and following standard operating procedures will help in getting an accurate performance evaluation of the system under test.
The transport simulation test plan will subject all the qualified components to normal expected extremes in the transport environment using simulated transport. It’s important to note that during actual transport, both the product and packaging are subjected to temperature, vibration, shock, pressure changes, and humidity simultaneously. The combination of these environmental transportation hazards can affect a product uniquely than when exposing the product to these hazards individually. Keeping this in mind, Modality has designed an Advantage Transport Simulation Laboratory that gives you the ability to concurrently simulate these five transportation hazards.
After the completion of transport simulation OQ test, long term stability studies and efficacy tests should be conducted on the product to demonstrate that a dynamic transport environment does not affect the product integrity. The last part of this series will talk about the steps involved in conducting a Performance Qualification, which is last component of the transport validation process.