Pharmacopoeia Compliance Series

In this series of articles, J. Mark Wiggins, owner and compendial consultant with Global Pharmacopoeia Solutions LLC, and Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC, provide an understanding about the need for pharmacopoeia compliance.

The following articles in this series can be viewed as webpages or as PDFs:

Why Pharmacopoeia Compliance is Necessary | View PDF

Why Pharmacopoeia Compliance is Difficult | View PDF

A Brief History of Pharmacopoeias: A Global Perspective | View PDF

Global Pharmacopoeia Standards: Why Harmonization is Needed | View PDF

Harmonization Efforts by Pharmacopoeias and Regulatory Agencies | View PDF

Revision Process for Global/National Pharmacopoeias | View PDF

Detailed Consideration of Global and National Pharmacopoeias

Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions | View PDF

Industry Pharmacopoeia Surveillance Process in Detail

Monograph Development: Why and When to Participate | View PDF

Monograph Development: How to Participate; How to Harmonize | View PDF

A Practical Approach to Pharmacopoeia Compliance | View PDF

A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials | View PDF

Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon | View PDF