Sue Mann, Sue Mann Consultancy
Annex 16 (Certification by a Qualified Person and Batch Release) of the EU GMP Guide describes the "handling of unexpected deviations". A batch with an unexpected deviation concerning the manufacturing process may be certified if the result of a risk analysis performed shows that "the potential impact of the deviation on quality, safety or efficacy of the batch(es) concerned and conclusion that the impact is negligible."
This flexibility might sound reasonable but puts a lot of responsibility on the QPs. There will always be borderline cases and ambiguities.
This Webinar has been designed for EU Qualified Persons (QP) but also QA personnel, upper management functions and other interested people who want to be informed about QP challenges when certifying batches.
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- Batch deviations and QP Certification: degrees of freedom and limits as defined in the guidance
- Discuss based on real-life scenarios:
- Potential risks and impact
- Batch certification possible or not
- Consequences and further actions
Recording from 05.08.2020
Duration of recording: about 1,5 h.