Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

Issue link:

Contents of this Issue


Page 25 of 43

26 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series T he pharmacopoeial revision process and the result- ing publication of proposed and official updates were described in a previous article in this series (1). To maintain ongoing compliance with current pharma- copoeia requirements as expected by regulators around the world, it is essential for bio/pharmaceutical companies to be aware of these periodic updates, so they can determine the potential impact and implement appropriate changes to their quality and regulatory documentation, as well as impacted processes and procedures. This article details the surveillance activities carried out by industry to monitor pharmacopoeia revisions so that companies can establish effective, efficient, sustainable, scalable, and successful processes to address these compliance challenges. Compendial affairs organization, roles, and responsibilities At a high level, effective surveillance is comprised of processes, people, and tools. These factors were described in an article written 15 years ago (2), and what is, perhaps, remarkable is that the issues and challenges have not substantially changed since then. Before delving into the details anew, it is helpful to look at one particular group that carries out key steps in the overall process. Although identified by a variety of names, in many compa- nies there is a group or function known as compendial affairs. The activities carried out by the compendial affairs group were described using the end-to-end framework in the second article of this series (3). The compendial affairs responsibili- ties include surveillance of the pharmacopoeial revision pro- cess, which may include publications for both proposed and official updates; advocacy, through responses to proposed changes; and compliance, through involvement in change control to enable implementation of official updates within the company. Another potential advocacy role for compendial affairs is through the submission of new or revised mono- graphs to provide quality standards in the pharmacopoeias for a company's drug products and ingredients. This activ- ity may also involve coordination within the company and with the pharmacopoeias to provide samples and standards to support monograph elaboration. Direct engagement with the J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC. Joseph A. Albanese is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC. iQoncept - Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions J. Mark Wiggins and Joseph A. Albanese 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. Published articles in this series are available online at • 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 • Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions Upcoming articles in this series will include the following: • Monograph Development: Why and When to Participate • Monograph Development: How to Participate; How to Harmonize • A Practical Approach to Pharmacopoeia Compliance • A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials • Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon

Articles in this issue

Links on this page

Archives of this issue

view archives of Pharmaceutical Technology - December 2019 - Pharmaceutical Technology - Regulatory Sourcebook