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www.biopharminternational.com eBook December 2019 BioPharm International 39 I m p l e m e n t i n g c o m p e n d i a l updates is made more difficult by the large number of revisions that must be addressed, and the assess- me nt s ne e de d b y m a ny S M E s and functional areas in the com- pany. There are likely instances where a proposed or official revi- sion that impacts the company may not have been identified, or the impact of the change has not been fully assessed by all stake- holders. Even if identif ied and assessed appropriately, there are times when the change control process is delayed, awaiting key decisions on implementation, as well as assessments by impacted a r e a s , i nc lu d i n g m a nu f a c t u r- ing sites and reg ulatory affairs. Updates to product registrations and gaining approval from regu- latory agencies around the world may take a long time due to the complexity of the work. In these situations, a manufacturing site may have to perfor m duplicate testing, using the old pharmaco- poeia requirements and the new ones, managing appropriate com- pliance in the interim until every- thing is realigned. These situations are often noted by leadership as failures in the pro- cess, and while this may be a valid perspective, it does not ref lect the majority of cases where these "misses" did not happen. Ideally, management expectations of the process will reflect this reality. In the authors' experience, one mea- sure of success for the compendial affairs function is "flying under the radar", going unnoticed by management because everything is proceed ing as expec ted a nd no compliance gaps emerge. All this success, however, may be for- gotten when a potential compli- ance gap is found. At this point, the success of the process relates to how quickly and how well the company's stakeholders can come toget her a nd add ress t he gap. Sufficient resources are needed for these implementation activities, potentially including method com- parability studies, to reach a suit- able outcome in a short time while other routine work is also main- tained by the f unctional areas. Learning from these situations can lead to continuous improvement in the surveillance process to min- imize the likelihood of another such occurrence in the future. CONCLUSION Details of the bio/pharmaceutical industry surveillance process have been provided to help address the compliance challenges resulting from pharmacopoeia revisions. The goal for an individual company is to establish an effective, efficient, sustainable, scalable, and successful process to accomplish the work. It is the people and tools that contribute to the effectiveness, efficiency, and sustainability of the process, and the benefits of advocacy activities are clear. The process can evolve over time, with more people and new tools added as resources are made available, which can also sup- port the scalability of the process to add more pharmacopoeias or products to the overall monitoring. Consideration of all these details determines the ultimate success of the process. Recalling the fundamental prin- ciple stated in the first article of this series (4), compliance with official requirements published by phar- macopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is appli- cable. However, there is flexibility in how a company complies, and this will be explored in later arti- cles. A future article will describe another advocacy opport unit y: collaboration with the pharma- copoeias for the submission and development of monographs. ACKNOWLEDGMENT The authors gratefully acknowl- edge the contribution of Susan J. Schniepp for her technical review and helpful suggestions during the preparation of this series of arti- cles. Sincere appreciation also goes to the compendial affairs group at Merck & Co., Inc. for valuable discussions over many years that helped shape the concepts and pro- cesses described in this article. REFERENCES 1. J.M. Wiggins and J.A. Albanese, "Revision Process for Global/National Pharmacopoeias," BioPharm International Regulatory Sourcebook eBook, 14–24 (December 2019). 2. N. A. Schwarzwalder and R. H. Bishara, American Pharmaceutical Review 7 (4), 53-57 (July–August 2004). 3. J. M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Difficult," BioPharm International Regulatory Sourcebook eBook, 26–34 (September 2019). 4. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Necessary," BioPharm International Regulatory Sourcebook eBook, 18–25 (September 2019). BP The success of a surveillance process can be measured by the on-time implementation of official pharmacopoeia revisions, a challenge due to the large number of revisions. Regulatory Sourcebook Pharmacopoeia Compliance Series

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