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Dr Bernd Renger
Dr Renger is a Qualified Person and runs his own consultancy. Prior to that he was VP Quality Control at Vetter Pharma-Fertigung GmbH. He began his career at Hoechst AG in 1977 and has since held various management positions in the quality area at Mundipharma, Byk Gulden (today Takeda), as well as at Baxter BioScience AG in Vienna. Dr. Renger is a member of the Board of the ECA Foundation and the ECA Visual Inspection Group and Immediate Past Chair of the European QP Association.
AQL testing as part of the visual inspection process is not so common yet. But still, questions often arise also in sites where this second testing has already been implemented. It is the webinar’s aim to provide assistance here and to explain the AQL testing concept.
How mandatory is AQL testing?
Is AQL testing part of production or quality control?
How are quality levels determined and how is the number of units to be inspected calculated
What does AQL testing look like for lyophilized products?
What has to be done when AQL limits are exceeded?
The requirement for injectables to be ‘essentially’ or ‘practically’ free of particles has been causing uncertainties for many years. On one hand ‘essentially free’ is not a measurable limit. On the other hand it is known that neither a manual nor an automated visible inspection is 100% free from error or defect. The implementation of AQL (Acceptable Quality Levels) testing as a part of the visual 100% inspection is a means of meeting the holistic approach of this control test. This is true for the manual as well as for the automated visual inspection.
Moreover, after the USP has included the AQL testing in chapter Visible Particulates in Injections as part of the whole inspection system, it is likely that other pharmacopeias will follow.
The webinar targets executives and staff from production and quality units who are in charge of the visual inspection of parenterals. But also Qualified Persons, responsible for the review and release of products for injection are within the target group of this webinar.
Furthermore, information on an error handling plan are provided if acceptance criteria cannot be fulfilled, an important topic which is also discussed in the current EMA GMP regulations.
The webinar also considers the validation protocol as an ideal tool for an instruction (SOP) to perform validation experiments.
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