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 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
Evolution of Analytical Procedure Validation Concepts: Part II
March 15th 2023This article focuses on drawing parallels between ICH Q14/Q2(R2), United States Pharmacopeia (USP) <1220>, and International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) 17025:2017.
