ABSTRACT
The three stages of process validation are to be applied to pharmaceutical manufacturing whether the manufacturing is performed by the drug sponsor or by a contract manufacturing organization. The three stages (process design, process qualification, and continued process verification) are generally led by different functions, and regardless of in-house or contracted manufacturing, different functions and organizations will have different viewpoints and incentives during each stage. The different views are necessary and in fact complement one another. One deals with technical details and the other with compliance essence. It is imperative to take an integrated team approach throughout the stages and have transparency to the different viewpoints, incentives, benefits, and risks.
