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

Joseph A. Albanese

Articles

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

Global Pharmacopoeia Standards: Why Harmonization is Needed (PDF)

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

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

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.