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Glossary

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

L

Listedness

An Adverse Event is considered “listed” if it is described in the product’s Company Core…

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O

Overdose

Administration of a quantity of a medicinal product given per administration or cumulatively which is…

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