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Critical Process Parameter (CPP)

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A process parameter whose variability has an impact on a critical quality attribute and therefore should be monitored or controlled to ensure the process produces the desired quality.


Other glossary definitions


Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities. Investigational…

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Briefing Book (or briefing materials)

Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation…

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