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Glossary

Potency

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(For Biologics) The measure of the biological activity using a suitably quantitative biological assay, based on the attribute of the product which is linked to the relevant biological properties.

 

Other glossary definitions

Q

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.…

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A

Audit

A systematic, disciplined, independent, and documented process for obtaining audit evidence and evaluating it objectively…

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