Why Pharmacopoeia Compliance Is Difficult–An End-to-End Compendial Framework (PDF)

September 15, 2019
J. Mark Wiggins

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

This article provides an end-to-end compendial framework to understand why compliance with pharmacopoeia standards is challenging.