Product Lifecycle Approach
As part of a new product licensing and launch for commercial distribution, a manufacturing process must be adequately defined and sufficient evidence must be provided that indicates the process can consistently produce a product that meets predefined quality attributes for identity, strength, quality, purity, and potency.
Process validation includes verification that the commercial manufacturing process is robust and the process parameters and quality attributes defined in the development and scale up of the process will consistently and reliably produce the product it was designed for,
Our typical methodology for process validation involves a risk-based product lifecycle approach that incorporates verification that all prerequisite quality systems for the manufacture of the product are in place prior to execution. This methodology leverages the following resources:
Our process validation experts develop a robust, scientifically sound, process validation strategy utilizing a cross-functional team approach that includes all departments involved in the manufacture, testing and release of commercial product.
An example of some of the studies that we typically perform that are associated with validation of the manufacturing processes for a product include the following:
Process Validation
Mixing Validation
Hold Studies
Shipping Validation