Pharmaceutical Technology - September 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 27 of 54

28 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series C ompliance with requirements published by phar- macopoeias around the world is a legal and regu- latory requirement in those countries and regions in which the pharmacopoeia is applicable. This fundamental principle of pharmacopoeia compliance is an important consideration for the bio/pharmaceutical industry, including innovator, generic, virtual, and start- up companies who discover, develop, manufacture, and distribute small-molecule drug products, biotherapeutic products, and vaccines, as well as the drug substances and excipients used in these products. Across the entire indus- try and within any given company, it is crucial that there is awareness and understanding of this need for pharma- copoeia compliance—from the CEOs of multi-national innovator and generic-drug companies to the leadership at small start-ups and contract manufacturers, to manag- ers in their respective functional areas, to the analytical bench chemists and microbiologists testing active ingre- dients and excipients for use in drug products—so that global patients have uninterrupted access to the critical medicines that extend and improve their lives. There is often insufficient understanding, however, by stakeholders at all levels of the need to comply with re- quirements in the pharmacopoeias. This situation can lead to a lack of appropriate attention and resources allocated to ensure compliance. The compliance risk can result in observations in FDA 483s, which may be summarized as follows: the company must comply with applicable com- pendial standards in the United States Pharmacopeia–Na- tional Formulary (USP–NF). A more nuanced observation is that the company must comply with "current" compen- dial requirements, which introduces the need to monitor and implement updates published in USP–NF. The situa- tion is not limited to the United States, as similar expecta- tions to comply with the applicable pharmacopoeia exist in Europe, Canada, Australia, Japan, China, and in laws and regulations around the world. The situat ion is made even more complex because a company must comply with the compendial require- ments that are applicable in a particular country, and also Why Pharmacopoeia Compliance Is Necessary 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. iQoncept -

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