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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

E

EMA HTA Parallel Scientific Advice

When developing a medicinal product, two milestones are of importance for making its path to…

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D

De Novo

The US Food and Drug Administration (FDA) automatically classifies Class I or II medical devices…

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