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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

F

Field Safety Corrective Action (FSCA)

A Field Safety Corrective Action is an action taken by a manufacturer to report any…

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I

Investigational Medicinal Product Dossier (IMPD)

Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the…

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