Implementing a Quality by Design (QbD) Program to Make Process Validation a Lifestyle Rather Than an Event

The FDA now defines process validation as "The collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products." On-going process validation is therefore the most important practical outcome of any QbD program. The process understanding needed to define, scientifically support and obtain regulatory approval for a process design space that achieves the required quality outcomes, requires self-service access for end users to all the process development and manufacturing data located in multiple data sources and on paper records. The data must be easily available to the process development, manufacturing and quality team in a meaningful context that includes the batch, data type and genealogy relationships. This collaborative environment should also include the appropriate ad hoc investigational analytics, trending and reporting capabilities needed to understand cause-and-effect relationships and build a sufficient process model of the relationships between CPPs and CQAs that allows effective process control within the process design space.