Pharmaceutical Technology - March 2020

Pharmaceutical Technology - Regulatory Sourcebook

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14 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m Pharmacopoeia Compliance Series T his article is a continuation of the series intended to provide a practical guide to pharmacopoeia compli- ance for the bio/pharmaceutical industry. The first articles provided details on why pharmacopoeia compliance is necessary (1) and why compliance is difficult to achieve and maintain (2). Subsequent articles provided a historical and global perspective of the pharmacopoeias (3) and described the benefits of global pharmacopoeia standards (4) that may be achieved through ongoing harmonization ef- forts (5). The process used to revise the pharmacopoeias was described (6) as was the associated surveillance process used by the industry to monitor these revisions (7) to facilitate on- going compliance with current pharmacopoeia requirements. It was noted that monitoring only the official revisions pub- lished by the pharmacopoeias puts a company in a reactive position to achieve compliance with updated requirements. Working further upstream to include surveillance of pro- posed updates published by the pharmacopoeias provides an opportunity for companies to take a more proactive position by providing comments to potentially influence the new and revised requirements that are proposed. This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through par- ticipation in the development of new and revised mono- graphs in the various pharmacopoeias. Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmaco- poeia revision process (6). The monograph is published by the pharmacopoeia as a proposed update, which in most cases moves forward to become the official standard for the material. Aligning the monograph with approved product registrations makes it easier for a company to achieve com- pliance with the requirements in the monograph. There is a need to answer practical questions regarding a company's participation in this monograph development activity, for example: • Why should a company submit a proposal for a new or revised monograph to the pharmacopoeia? • What is the appropriate timing—in various situa- tions—for submitting a monograph? How long will it take for the monograph to be completed? 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 - Stock.adobe.com Monograph Development: Why and When to Participate 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 www.PharmTech.com/compendia: • 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 • 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

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