Translation 6: Process Validation

Increasing the production scale of a product in development from lab to pilot then on to full scale is an important aspect to manage correctly during the transition of a product from the laboratory to manufacturing. It requires careful planning, execution and monitoring to ensure the development of a robust and reproducible GMP process. This module will outline how to plan, design and conduct representative pilot scale operations, to demonstrate process scalability, identify and address potential issues before commencing full-scale production.