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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.
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
Why Pharmacopoeia Compliance is Difficult
A Brief History of Pharmacopoeias: A Global Perspective
Global Pharmacopoeia Standards: Why Harmonization is Needed
Harmonization Efforts by Pharmacopoeias and Regulatory Agencies
| Revision Process for Global/National Pharmacopoeias | View HTML | View PDF |
| Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions | View HTML |
| Monograph Development: Why and When to Participate | View HTML |
| Monograph Development: How to Participate; How to Harmonize | View HTML |
| A Practical Approach to Pharmacopoeia Compliance | View HTML |
| A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials | View HTML |
| Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon | View HTML |
