Pharmacopoeia Compliance Series

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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.

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 can be found within this series:

Why Pharmacopoeia Compliance is Necessary

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Why Pharmacopoeia Compliance is Difficult

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A Brief History of Pharmacopoeias: A Global Perspective

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Global Pharmacopoeia Standards: Why Harmonization is Needed

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Harmonization Efforts by Pharmacopoeias and Regulatory Agencies

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Revision Process for Global/National PharmacopoeiasView HTMLView PDF
Surveillance Process for Industry: Monitoring Pharmacopoeia RevisionsView HTML
Monograph Development: Why and When to ParticipateView HTML
Monograph Development: How to Participate; How to HarmonizeView HTML
A Practical Approach to Pharmacopoeia ComplianceView HTML
A Case Study in Pharmacopoeia Compliance: Excipients and Raw MaterialsView HTML
Pharmacopoeia Compliance: Putting it All Together; What is on the HorizonView HTML