9. Glossary

APIs (active pharmaceutical ingredients); active ingredient

CQA (critical quality attribute)

A physical, chemical, biological or microbiological property or feature that must be within an acceptable range.

CPPs (critical process parameters)

CMAs (critical materials attributes)

FMECA (failure mode, effects and criticality analysis)

Systematic method for identifying and preventing product or process problems.

FPP (finished pharmaceutical product); produit fini pharmaceutique (finished pharmaceutical product)

Pharmaceutical product in a fixed dosage and form that has undergone all production stages, including packaging in its final packaging.

ICH (International Conference...