Recording Webinar: Ongoing/Continued Process Verification - How to Implement it in Small and Medium-sized Companies

With the change of FDA´s process validation guideline from 1987 and the Annex 15 of EU GMP Guide, a validation life cycle entered the validation world. The development, the validation of the manufacturing process/ Process Performance Qualification (PPQ) and the Ongoing/Continued Process Verification are now the current validation stages. Especially the requirement for a stage 3 is a challenge for enterprises as this stage is new and did not exist before the validation life cycle. The Ongoing/Continued Process Verification will substitute revalidation in most cases. It supplements the Product Quality Review (PQR) or Annual Product Review (APR), which is usually written in the USA every year. The FDA Process Validation Guidance requires statistically sounded data evaluated from a statistically trained person.  Both in Europa and in the USA, this stage 3 is intended to show that the process is in “control of state”. This applies to the single batches (intra-batch-variabilities) and to the comparison of single batches with each other (inter-batch-variabilities).This gives rise to a number of questions. Which data of a manufacturing process should be evaluated in an Ongoing/Continued Process Verification according to a rationale? How is the statistical sampling in this context? What statistical indicators are required? How can the requirements be implemented in small and medium-sized companies in a pragmatic way?

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