Quality Systems

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

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

Articles

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world. 

Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon

The revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world are described.

Revision Process for Global/National Pharmacopoeias

This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.

Revision Process for Global/National Pharmacopoeias (eBook)

An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions

An understanding of global and national pharmacopoeias is crucial to understanding change processes and access to different markets.

Detailed Consideration of Global and National Pharmacopoeias

The process used to monitor and participate in pharmacopoeial changes is described.

Industry Pharmacopoeia Surveillance Process in Detail

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (PDF)

Revision Process for Global/National Pharmacopoeias (PDF)

This article examines the history and evolution of the pharmacopoeias and the particular challenges that must be overcome to achieve harmonization among the pharmacopoeias.

Pharmacopoeial Compliance Series