Transportation Can Be Validated Like Any Other Process
In today’s worldwide marketplace, your products will be transported across the globe; numerous factors can affect their efficacy and stability through shelf life. Our goal at Modality Solutions is to design and validate a cold chain controlled-environment logistics solution for products which includes the required validation master plan, documented protocols and reports, and summary of your process validation for your BLA or marketing authorizations around the world.
Modality Solutions provides experience and value-added knowledge around cGDP compliance and regulatory inspections for packaging qualification and transport validation for controlled-environment logistics worldwide--with over a dozen marketing approvals and hundreds of successful inspections. As an example of the challenges we take on for our clients--a manufacturer needs to provide product and process validation data to demonstrate product quality can be maintained during transport; the packaging provided can adequately maintain the environment; and the multiple partners in the supply chain can ensure that the handling methods are satisfactory and reproducible. Many variables can influence product integrity during the logistics process, including: environmental extremes, packaging degradation, courier mishandling, import/export requirement delays, seasonal changes, transit time and even the day of week for shipping!
The Future of Transport Validation
Increasing regulatory scrutiny on global supply chain process controls mean more product and process data will be needed to show that the stress introduced during transport does not impact product quality or reduce shelf life. Current static accelerated stability studies will need to be augmented with 'dynamic' or 'stress' stability studies. These studies can be conducted in uncontrolled 'real world' transport studies or simulated in a laboratory environment. Regardless of how the data was originally developed, submitted and approved, the product and process will have to be re-characterized and possibly re-validated. Any changes may require a redesign of packaging, logistics controls, and/or environmental monitoring.
Our multi-disciplinary team is ready to help you with your cold chain needs or existing program. For more information, contact us today.