The Quality by Design principles and the new FDA Draft Process Validation Guidance, based on the QbD philosophy, points towards an approach process validation based on the scientific product and process knowledge. In Europe EMA has announced a concept paper for the update of the EU Guideline for Process Validation.
How can pharmaceutical companies take advantage of the new principles in future process validation and facility verification?
We are in the middle of a potential paradigm shift for process validation in the pharmaceutical industry. The new regulations in the US, the international harmonization towards ICH Q8, Q9 and Q10 Guidelines and the increasing application of science- and risk based principles for a more
cost-effective and quality conscious approach, gives significant new opportunities.
Times are changing from the time when process validation was known as the ‘3 batches’ to the potential future of continuous process verification. This future is what we look into with this conference.