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.