- What was the biggest change leading to the revision of the Validation Process approach?Validation of an API or pharmaceutical product manufacturing process has historically been a kind of bureaucratic exercise, consisting of three batches meeting specification, making use of standard Batch Records and using a Validation Protocol and Report (often based on a standard template).
The new approach covers the whole Product Life Cycle activity ; ongoing activity starting at development scale-up and followed until the commercial scale. Process parameters and ranges are based on Design Of Experiments (DOE).
- In your opinion, what is the main difference between the classical and modern approach?Through this new approach, the concept of Process Validation appears as an important value for the company not only to pass inspections but also to increase knowledge, reduce incidences and at the end, enhance efficiency – adjusting efforts to actual needs.
- How can quality by design and risk management assure continual improvement under ICH Q8 and Q11? Can you give us an example?ICH Q8 and ICH Q11 provide guidelines on how to proceed to generate and manage knowledge about the process. Risk Management is a tool to be used throughout all stages of development to optimize efforts and to ensure process robustness and safety.
When the process is developed through the Quality by Design concept, the critical operations are identified through risk analysis, and in combination with experimentation, the best ranges for the parameters are characterized. The result is a robust process leading to a fluent scale-up and industrialization. On the other hand, routine exception management will be fluent as well.
- What is your biggest expectation for the upcoming conference?The conference’s takeaway should be basically changing the way of thinking about the validation concept. New insights show that an optimized validation approach results in benefits from the business point of view as well.