Active Pharmaceutical Ingredients (APIs) A substance used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
Related Guidance Documents
Active Pharmaceutical Ingredients (3)
Drug Shortages (1)
Good Manufacturing Practice (1)
Project Management (1)
Supply Chain Management (1)
Community Discussions
Community Discussions
Dec 20, 2024
Dec 19, 2024
GAMP®
Dec 18, 2024
Dec 16, 2024
Biotechnology
Containment
Dec 11, 2024
Data Integrity
Dec 04, 2024
Good Manufacturing Practice
Dec 04, 2024
GAMP®
Lifecycle Management