A client recently wrote: "We are seeking validated information proving that a change in manufacturing procedure will provide a product that is equal to or superior to that supplied previously.We know that the benefits of the proposed change are significant with respect to component cost reduction and labor saved.The relatively new concept of validation likely will be used more and more by customers and certifying agencies to ascertain that all conceivable means were used to guarantee that a manufactured product indeed meets all requirements, including hidden characteristics not readily verifiable.This article gives an overview of typical applications.Demonstration that the process-control system can reach and detect when acceptable product is produced may include a set of start-up and shutdown activities.The number of start-ups and shutdowns could be determined based on a risk analysis and the unique critical considerations for that process; examples may include process robustness, process flow rate and residence time, and the number and inter-relationship of CPPs/CQAs.The earlier guidelines were developed before the elaboration of the new ICH guidelines.With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches.
The difference is in the implementation, desired outcome and the phase of the process.
Designing and running accelerated endurance tests with carefully selected parameters (moderately exceeding the norm to make up for the reduced time) can help you determine which of the proposed solutions creates a better-performing, longer-lasting part.
Will the proposed change improve or worsen availability and functionality?
Considerations for continuous manufacturing process validation should demonstrate that the process is under control and can achieve expected performance.
These include start-up and shutdown of the process, process run-time evaluation, and the ability to detect process excursions.