BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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www.biopharminternational.com September 2019 BioPharm International eBook 27 Regulatory Sourcebook Pharmacopoeia Compliance Series 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 www.BioPharmInernational.com/compendia: • 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 mon itor i ng of pha r macop o e ia publications (including both pro- posed and official changes) and implementation of these changes in the impacted quality, regula- tory, and site/functional area pro- cedures and doc uments. W hile this represents the essential com- pliance perspective, it does not adequately capture the totality of work that is typically required for the compendial affairs function within a given bio/pharmaceuti- cal company. A comprehensive v iew of t hese ac t iv it ies ca n be fou nd t h roug h a n e nd -to - e nd c o n s i d e r a t i o n o f c o m p e n d i a l affairs. At a high level, the functions performed by individuals in the compendial affairs area typically include strategy, surveillance, and implementation within an overall framework of ongoing compliance w it h c u r r e nt p h a r m a c o p o e i a r e q u i r e m e nt s . E a r l y s t r a t e g y activities are aimed at proactive advo c ac y to b et ter enable t he final objective, which is on-time implementation and compliance w it h i n t he i mpac ted sites a nd functional areas that must meet t he c omp e nd i a l r e qu i r e me nt s published by the pharmacopoe- ias when they become off icial. Between the strategy and imple- mentation functions are the criti- cal surveillance activities, which include review of new and revised compend ia l requ i rements, i n i- tially at the proposal stage and subsequently when they become official and enforceable. The work done during compendial surveil- lance provides an opportunity for advocacy; although in this case, it is in reaction to the proposed revi- sions. In the authors' experience, the upstream, proactive advocacy is often more effective than the reactive, dow nstream advocac y in inf luenc ing t he outcome of compendial changes. Surveillance also provides the ability to plan for i mple me nt at ion whe n t he pharmacopoeia updates become o f f i c i a l , w h i c h c a n b e v e r y beneficial to help ensure on-time compliance. This high-level overview of com- pendial activities, however, does not convey the significant effort required to establish and maintain compliance with current compen- dial requirements. A comprehen- sive, detailed picture of this work is provided in Figure 1. With the ultimate and essential goal being c omp e nd i a l c ompl i a nc e, it i s instructive to explore the details looking first at the final stages of the overall process.

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