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Glossary

Critical Quality Attribute (CQA)

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A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

 

Other glossary definitions

I

International Birth Date (IBD)

The date of the first marketing authorization for any product containing the active substance granted…

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E

Expectedness

An Adverse Event is considered “expected” if events are symptomatically and physio-pathologically similar to those described…

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