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Page 14 of 42 eBook December 2019 BioPharm International 15 "global" or "national" can help give visibility to some of the dif- ferences between them, and can, in turn, assist individual compa- nies in focusing their compendial work on those activities that help ensure compliance with pharma- copoeial requirements. DEFINING GLOBAL AND NATIONAL PHARMACOPOEIAS In the second article of this series (2), brief definitions were provided for "national" and "global" phar- macopoeias. • National pharmacopoeias form the legal requirements in their individual countries and are important for ensuring access to medicines for patients in these specific markets. • G l o b a l p h a r m a c o p o e i a s form the legal requirements in their country/region and are acceptable to reg ulatory agencies well beyond the geo- graphical boundaries covered by the pharmacopoeia, ensur- ing access to medicines for patients at a global level. It is helpful to consider these designations in more detail (see Sidebar pp. 20 –21). Throughout t h e s e a r t i c l e s , t h e E u r o p e a n Phar macopoeia (Ph. Eur.), British Phar macopoeia (BP), and United S t a t e s P h a r m a c o p e i a – N a t i o n a l Formulary (USP–NF) are considered global pharmacopoeias, based on t hei r accepta nce by reg u lators a round t he world. Ma ny ot her i mpor ta nt pha r macopoeias are considered national. REVISION PROCESS FOR GLOBAL PHARMACOPOEIAS In their article (6), Schwarzwalder a n d B i s h a r a m a d e t h e c r it i - ca l poi nt, "… pha r macopoeia l requirements are not static, and continued compliance demands that companies in this regulated industry be alert to changes." The article continues, "(a) program for rev iew ing pharmacopoeial pro - posals and implementing changes is needed to ensu re cont inued compliance." Surveillance activities used by bio/pha r maceut ic a l compa n ies are triggered by the publication of new a nd rev ised pha r maco - poeial requirements. The publica- tion schedule, in turn, is driven by the pharmacopoeia rev ision process. T he ongoi ng rev ision of pharmacopoeias can be initi- ated in several ways. For exam- ple, pharmacopoeia changes can be driven by a significant tech- n o l o g y u p d a t e t h a t r e q u i r e s a general chapter to be revised. Changes could be started to reflect a new International Council for Har monization (ICH) g uidance (e.g., Q3D) with impact to both e x i st i ng ge ne ra l c hapte r s a nd to monographs for many mate- r ia ls. Pha r macop o e ia l up d ates may be driven by collaborative e f for t s to ac h ieve ha r mon i z a- tion, as with the activities of the Pharmacopoeial Discussion Group (PDG), which is comprised of rep- resentatives from the Ph. Eur., USP, and the Japanese Phar macopoeia ( JP). Phar macopoeial evolution can be sparked by industry with the submission of a new or revised monograph. With so many pos- sible avenues for change, the sit- uat ion clea rly dema nds t hat a company have a process for moni- toring and staying up to date with the continuous revisions in the pharmacopoeias. But obviously, monitoring is not enough, since impac t assessment a nd cha nge control are needed to enable ongo- ing compliance with the current re qu i re me nt s. T hese con side r- ations will be discussed in later articles. Regulatory Sourcebook Pharmacopoeia Compliance 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 www. • 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 A Practical Guide to Pharmacopoeia Compliance: A Series

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