Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 35 of 54

36 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series F or the bio/pharmaceutical industry, compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmaco- poeia is applicable. This article provides a comprehensive, end-to-end framework to help companies who discover, develop, manufacture, and/or distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these products, to better understand the external and internal challenges that make pharmacopoeia compliance difficult. Understanding the challenges enables an exploration of the approaches that may be taken to help ensure ongoing com- pliance with pharmacopoeia requirements. An end-to-end framework for pharmacopoeia compliance The critical question that must be asked is: what is necessary for compendial compliance? The answer is provided in an ar- ticle describing the bio/pharmaceutical industry's pharmaco- poeial surveillance process (1): a company must comply with current pharmacopoeia requirements. This was true when the article was written 15 years ago and is still true today. Ongoing compliance requires timely and effective monitoring of phar- macopoeia publications (including both proposed and official changes) and implementation of these changes in the impacted quality, regulatory, and site/functional area procedures and documents. While this represents the essential compliance perspective, it does not adequately capture the totality of work that is typically required for the compendial affairs function within a given bio/pharmaceutical company. A comprehensive view of these activities can be found through an end-to-end consideration of compendial affairs. At a high level, the functions performed by individuals in the compendial affairs area typically include strategy, surveillance, and implementation within an overall framework of ongoing compliance with current pharmacopoeia requirements. Early strategy activities are aimed at proactive advocacy to better en- able the final objective, which is on-time implementation and Why Pharmacopoeia Compliance Is Difficult An End-to-End Compendial Framework 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. The following articles can be found within this ebook and 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 Upcoming articles in this series will include the following: • Revision Process for Global/National Pharmacopoeias • Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions • 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 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. oatawa-

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