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

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 (eBook)

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

Evaluating Regulatory Trends Globally and Regionally

Regulatory agencies published guidelines to advance drug development, streamline submission processes, and promote biosimilars. 

What’s New in Regulations and 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.

Pharmacopoeia Compliance Series

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

A Brief History of Pharmacopoeias: A Global Perspective (PDF)

The authors take a closer look at these ongoing efforts to harmonize compendial standards, with perspective that may be helpful in considering the future direction of pharmacopoeias.

Harmonization Efforts by Pharmacopoeias and Regulatory Agencies (PDF)

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

Phil Borman, DSc, has served in multiple quality-related roles at GlaxoSmithKline; as of April 2021, he is senior fellow and director of product quality.

Fumiko Tamura is associate manager, GSK, CMC Regulatory Affairs, Tokyo, Japan

Hatsuki Asahara is department manager with GSK, CMC Regulatory Affairs, Tokyo, Japan

Adam Watkins is scientific leader, GSK, product development and supply, David Jack Research Centre, Ware, UK.

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies. 

Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.

Compendial Compliance