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

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


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Timur Güvercinci, Merck Healthcare KGaA, Darmstadt and self-employed GMP Trainer and Consultant


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?

Target Group

Employees from companies, who are involved in pharmaceutical process validation activities (developers, QM, manufacturing, heads of validation departments, etc.) especially regarding stage 3 ongoing/continued process verification, are addressed. Of course consultants in this field, who want to get information from the view of the medicinal product manufacturers, are addressed too

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The following issues will be discussed:
  • The Validation Life Cycle – FDA and Annex 15 requirements
  • Specific characteristics of stage 3 Ongoing/Continued Process Verification
  • What data have to be monitored?
  • How to set up a statistical sampling plan?
  • Statistical indicators for stage 3
  • Proposals for implementaton for small and medium-sized enterprises
  • Examples of FDA findings (Warning Letters)
Recording from 03.06.2020
Duration of recording: 1,5 h.

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