Cold Chains (#coldchain) are common and one of the basic necessities when it comes to Food and Pharma Industry. Members of the pharmaceutical supply chain have various global regulatory requirements to meet while handling, storing, and distributing environmentally sensitive products. Their focus is to provide cold chain management for temperature sensitive pharmaceuticals to ensure that the quality and efficacy of the product will not be compromised.
Traditionally all historical stability data developed for vaccines were based on the temperature range of 2-8Â Â°C. With recent development of biological products by former vaccine developers (#Drugdiscovery), biologicsÂ (#biologics)Â has fallen into the same category of storage at 2-8Â Â°C due to the nature of the products and the lack of testing these products at wider storage conditions.
A cold chain can be managed by aÂ quality management system. It should beÂ analyzed, measured, controlled, documented, andÂ validated. The overall approach toÂ validationÂ 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 atÂ 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.
New guidances outline a comprehensive view of cold chain managementÂ across the supply chain including: manufacturers, warehousers, distributors, transporters, and retailers. Trends of recent regulatory inspection citations demonstrate an increased focus on the factors affecting these labile preparations and ensuring their quality and integrity. Due to the presence of multiple uncontrolled variables in the distribution process, developing anÂ appropriate monitoring program is essential.
Michael Lee, VP, Manufacturing, Biomabs Pharmaceuticals, China, will be presenting at the Pharma and Biotech Supply Chain World Asia 2012 this March about "Balancing Flexibility in cold chain movements with retention of the integrity and quality of pharmaceuticals."