Challenges and Prospects for Filling the Certificate of Suitability in the European Union

Authors

  • Prabhakar Raju Pippalla, Raghava.D, Nageswara rao. K, Naga Sravani.P Author

DOI:

https://doi.org/10.48047/

Keywords:

Certificate of Suitability, cep, European pharmacopeia, EDQM, Regulatory Affairs, API Compliance, GMP, EMA

Abstract

The Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) is a critical regulatory document required for the marketing of pharmaceutical substances in the European Union. It demonstrates that the quality of a substance 

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Published

2025-10-07

Issue

Vol. 16 No. 10 (2025): Volume 16 Issue 10 (2025)

Section

Articles