BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Page 36 of 44 September 2019 BioPharm International eBook 37 Regulatory Sourcebook Pharmacopoeia Compliance Series of the United States Pharmacopeia (U S P ). T h i s i s a l s o t r u e at a regional level, as in the creation of the European Pharmacopoeia (Ph. Eur.), which established harmo- nized standards for medicines in Europe where individual country- specific standards had previously existed. And this is true in the ini- tial intention of the International Pharmacopoeia (Ph. Int.) to develop a u n i f ied pha r macopoeia t hat could be used around the world. In this context, it may be sug- ge ste d t h at h a r mon i z at ion i s embedded in t he development and history of the pharmacopoe- ias. However, the pharmacopoeias are themselves embedded within the current regulatory and legal framework of the country or region in which they are applicable. The intersection of the pharmacopoeias and regulatory agencies impacts the direction and approaches taken to move toward harmonization at a global level. Pharmacopoeia har- monization provides better sup- port for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufactur- ing and supply, which ultimately benefits global patients who rely on these medicines to extend and improve their lives. This article provides some industry perspective on the need to harmonize com- pendial standards, which may be helpful in considering the future d i r e c t ion of ph a r m acop o e i a s . These considerations are important because the sheer number of phar- macopoeias and the current lack of broad harmonization add complex- ity to a company's processes for compendial monitoring and com- pliance. A WORD ABOUT "HARMONIZATION" T he h i stor y of pha r macop o e - ias since the earliest times has reflected the goal of creating con- sistent standards for medicines that are used by those who need them. The process of achieving these con- sistent standards may be described as standardization, harmoniza- tion, or any of a number of other words that have a similar mean- ing. Before delving into some of the ongoing activities to achieve consistent compendial standards in today's global environment for medicines, it is prudent to first address potential concerns with the term "harmonization" itself. Recent discussion has suggested that it may be preferable to shift from using the word "harmoniza- tion" to instead use "convergence" in the context of pharmacopoe- 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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