Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 16 of 43

Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 17 Pharmacopoeia Compliance Series T he first article of this series about compendial ac- tivities in the bio/pharmaceutical industry stressed that compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable (1). The second ar- ticle provided an end-to-end compendial framework to aid in understanding many of the challenges with ensuring compliance (2). One significant factor that makes compli- ance challenging is the multiple pharmacopoeias around the world and the lack of broad harmonization of the re- quirements and standards they each contain. Subsequent articles explored the history of pharmacopoeias and the current global situation (3), with consideration of the po- tential benefits of compendial harmonization and a descrip- tion of current activities to achieve global pharmacopoeia standards (4, 5). Another challenge is the significant volume of new and revised requirements, which are published by the pharmaco- poeias as both proposed and official changes. It is essential for bio/pharmaceutical companies to monitor these peri- odic updates to ensure ongoing compliance. The surveil- lance process used by the industry is driven by the revision process and publication schedules of the pharmacopoeias. Designating pharmacopoeias as either "global" or "national" can help give visibility to some of the differences between them, and can, in turn, assist individual companies in fo- cusing their compendial work on those activities that help ensure compliance with pharmacopoeial requirements. Defining global and national pharmacopoeias In the second article of this series (2), brief definitions were provided for "national" and "global" pharmacopoeias. • National pharmacopoeias form the legal requirements in their individual countries and are important for ensuring access to medicines for patients in these specific markets. • Global pharmacopoeias form the legal requirements in their country/region and are acceptable to regulatory agencies well beyond the geographical boundaries cov- ered by the pharmacopoeia, ensuring access to medi- cines for patients at a global level. Revision Process for Global/National Pharmacopoeias 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 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 -

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