Manufacturing and Production

Process Validation and Qualification in Pharmaceutical Manufacturing

Validation is frequently run as a documentation exercise completed once and filed, which produces a folder that satisfies nobody and a process that nobody actually understands. This course treats it as the lifecycle it is. Delegates work through the three stages, process design, process qualification and continued verification, and what each is meant to establish. Critical quality attributes and critical process parameters are covered, including how they are identified rather than asserted. Design space and the relationship between parameters follow. Equipment qualification is addressed across design, installation, operational and performance stages, with the documentation each requires. Process performance qualification batches are covered, including how many and why. Sampling plans and statistical justification follow, since a plan without statistics cannot support a conclusion. Continued process verification is addressed with control charts and trend review. Change control and revalidation triggers are covered. The course closes on validation master planning and on defending a validation package to an inspector.