BioPharm International - December 2019

BP1219_Ebook-Regulatory

Issue link: https://www.e-digitaleditions.com/i/1193175

Contents of this Issue

Navigation

Page 26 of 42

www.biopharminternational.com eBook December 2019 BioPharm International 27 at one particular group that carries out key steps in the overall process. Although identified by a vari- ety of names, in many companies there is a group or function known as compendial affairs. The activi- ties carried out by the compendial affairs group were described using the end-to-end framework in the second article of this series (3). The compendial affairs responsibilities include surveillance of the phar- macopoeial revision process, which may include publications for both proposed and official updates; advo- cacy, through responses to proposed changes; and compliance, through involvement in change control to enable implementation of offi- cial updates within the company. Another potential advocacy role for compendial affairs is through the submission of new or revised mono- graphs to provide quality standards in the pharmacopoeias for a com- pany's drug products and ingredi- ents. This activity may also involve coordination within the company and with the pharmacopoeias to pro- vide samples and standards to sup- port monograph elaboration. Direct engagement with the pharmaco- poeias and participation in industry trade association activities provide other avenues for advocacy and shar- ing of best practices and perspectives on compendial issues. In this role, the individuals in compendial affairs also serve as the single point of con- tact (SPOC) in interactions with the pharmacopoeias. Finally, the com- pendial affairs group should serve as the internal support for the entire company, providing knowledge and experience in all things related to the pharmacopoeia. C o n s id e r i n g t he nu me r o u s responsibilities listed above, each company's approach to resourcing the compendial affairs function can be very different. Benchmarking of the bio/pharmaceutical industry revealed that some major multi-na- tional companies have three to five full time employees in a compen- dial affairs role. The more common approach, however, is that a single individual or a couple of individ- uals with part time responsibility comprise the compendial affairs functions. Of course, the fewer the resources available in a company's compendial affairs function, the more challenging it becomes to con- sistently carry out all the responsi- bilities necessary to ensure ongoing compliance. One company utilizes an outsourcing model for monitor- ing pharmacopoeia revisions, estab- lishing a SPOC in the company to manage the surveillance process that is carried out by external contrac- tors. This approach can reduce the cost of using internal resources for that part of the effort, which is con- sidered largely administrative. The external team can execute the review and filtering process and then assign the identified items with poten- tial impact to a company's internal groups for complete assessment. Another consideration is where within a company the compendial affairs function should reside (1). Key to this organizational decision is realizing that many functional areas in a company may be impacted by pharmacopoeial requirements. In one sense, it can be argued that compendial affairs could fit any- where within a company, while the practical reality is that this function does not seem to fit well anywhere. Benchmarking has shown compen- dial affairs to be organized within the quality, regulatory, or research and development f unctions, or even at a corporate level due to the broad impact. There is no right or wrong organizational approach, but 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. BioPharmInternational.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 • 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

Articles in this issue

Links on this page

Archives of this issue

view archives of BioPharm International - December 2019 - BP1219_Ebook-Regulatory