BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Page 18 of 44 September 2019 BioPharm International eBook 19 Regulatory Sourcebook Pharmacopoeia Compliance Series T he r e i s o f te n i n s u f f ic ie nt understanding, however, by stake- holders at all levels of the need to comply with requirements in the pharmacopoeias. This situa- tion can lead to a lack of appro- pr iate at tent ion a nd resou rces 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 compendial standards in the United States Pharmacopeia– National For mular y (USP–NF ). A more nuanced observation is that the company must comply with "c u r rent " compend ia l requ i re - ments, which introduces the need to monitor and implement updates published in USP–NF. The situation is not limited to the United States, as similar expectations to comply with the applicable pharmacopoeia exist in Europe, Canada, Australia, Japan, China, and in laws and reg- ulations around the world. T he sit u at ion i s made eve n more complex because a company must comply with the compendial requirements that are applicable in a particular country, and also with their product registrations as approved in countries around the world. This is true whether the pharmacopoeia references are spe- cifically listed in the registration, or because the pharmacopoeias provide additional, well-recognized qualit y standards. T he compli- ance challenge is increased by the sheer number of pharmacopoeias that exist in important markets, of ten w ith conf licting require- ments due to lack of harmoniza- tion among the pharmacopoeias. T his lack of broad har moniza- tion is the current reality, despite long-term commitment and effort by pharmacopoeias to narrow the div ide bet ween their published standards. Somewhat balancing this high-level view of the com- pliance challenge is the fact that there is some flexibility in how a company ensures appropriate com- pliance to the multitude of com- pendial requirements. But in this flexibility, there is also complexity, due to the number of approaches that may be taken to demonstrate compliance, with the potential for different situations to drive the approach in different directions. It is against this challenging backdrop that the authors have undertaken the preparation of a series of articles to provide a com- mon understanding of this far- reaching and complex situation and to detail practical ways that pharmacopoeia compliance may A Practical Guide to Pharmacopoeia Compliance: A Series 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 to establish effective processes, partnerships, and tools to maintain appropriate and timely compliance across the bio/pharmaceutical industry to the benefit of patients. 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

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