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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 37 ficial revision can be the basis for the company to request a new revision to the general chapter or monograph, pro- viding additional rationale or scientific data to support the requested change. The advocacy part of the compendial process can be very rewarding when comments are accepted by the phar- macopoeia authorities. It can be equally frustrating when sound scientific rationale may not be accepted, leaving a potential compliance gap for the company. It can be diffi- cult to explain to company scientists and management that the comments were not accepted, and that procedures and documentation may need to be changed to ref lect the of- ficial requirements. Another frustrating and challenging aspect of the compendial process may be encountered as a result of differing timelines followed by the pharmacopoeias to make harmonized requirements official, as has been seen with the updated chapters on residual solvents and elemen- tal impurities to align with the corresponding International Council for Harmonization (ICH) guidelines. Still, advocacy is a critical part of the compendial process and can result in an official revision that is easier to implement than it would have been if comments had not been submitted. Compliance. The ultimate goal of the industry surveil- lance process for monitoring pharmacopoeia revisions is to maintain ongoing compliance with current requirements, as expected by regulatory agencies around the world. The success of a company's process can be measured by on-time implementation of official pharmacopoeia revisions. Implementing compendial updates is made more difficult by the large number of revisions that must be addressed, and the assessments needed by many SMEs and functional areas in the company. There are likely instances where a proposed or official revision that impacts the company may not have been identified, or the impact of the change has not been fully assessed by all stakeholders. Even if identified and assessed appropriately, there are times when the change control pro- cess is delayed, awaiting key decisions on implementation, as well as assessments by impacted areas, including manufactur- ing sites and regulatory affairs. Updates to product registra- tions and gaining approval from regulatory 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 perform duplicate testing, using the old pharmacopoeia re- quirements and the new ones, managing appropriate compli- ance in the interim until everything is realigned. These situations are often noted by leadership as failures in the process, and while this may be a valid perspective, it does not reflect the majority of cases where these "misses" did not happen. Ideally, management expectations of the process will ref lect 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 proceeding as expected and no compliance gaps emerge. All this success, however, may be forgotten when a potential compliance gap is found. At this point, the success of the process relates to how quickly and how well the com- pany's stakeholders can come together and address the gap. Sufficient resources are needed for these implementation ac- tivities, potentially including method comparability studies, to reach a suitable outcome in a short time while other routine work is also maintained by the functional areas. Learning from these situations can lead to continuous improvement in the surveillance process to minimize 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 con- tribute 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 support 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 principle stated in the first ar- ticle of this series (4), compliance with official requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. However, there is f lexibility in how a company complies, and this will be ex- plored in later articles. A future article will describe another advocacy opportunity: collaboration with the pharmaco- poeias for the submission and development of monographs. Acknowledgment The authors gratefully acknowledge the contribution of Susan J. Schniepp for her technical review and helpful sug- gestions during the preparation of this series of articles. 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 processes described in this article. References 1. J.M. Wiggins and J.A. Albanese, "Revision Process for Global/ National Pharmacopoeias," Pharmaceutical Technology Regula- tory Sourcebook eBook, 17–25 (December 2019). 2. N. A. Schwarzwalder and R. H. Bishara, American Pharmaceu- tical Review 7 (4), 53-57 (Jul-Aug 2004). 3. J. M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Com- pliance Is Difficult," Pharmaceutical Technology Regulatory Sourcebook eBook, 36-42 (September 2019). 4. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compli- ance Is Necessary," Pharmaceutical Technology Regulatory Sourcebook eBook, 28–34 (September 2019). PT