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

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.

Global Pharmacopoeia Standards: Why Harmonization is Needed (eBook)

Why Pharmacopoeia Compliance Is Difficult (eBook)

Why Pharmacopoeia Compliance Is Necessary (eBook)

Find links to pertinent regulatory and standard setting resources, guidance documents, and guidelines.

Resources, Guidelines, and Guidance Documents

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations

This article provides the legal and regulatory basis for pharmacopoeia compliance and illustrates pharmacopoeia impact throughout the drug product lifecycle.

Why Pharmacopoeia  Compliance Is Necessary

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

Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply.

Regulatory/GMP Compliance, Emerging Markets