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28 BioPharm International eBook December 2019 the key consideration is that com- pendial affairs functions are criti- cal to ongoing compliance. The individuals or group assigned these responsibilities need to have man- agement support across the company to effectively address the impact of pharmacopoeia revisions, ensuring the necessary tasks are assigned the appropriate priority. INDUSTRY SURVEILLANCE PROCESS: PURPOSE AND SCOPE Perhaps the most important of the compendial affairs responsibilities is surveillance of pharmacopoeial revi- sions. A detailed description of the industry surveillance process is pro- vided in the Sidebar to this article. The purpose of this surveillance is to identify, communicate, and enable assessment of the potential impact resulting from updates to pharmaco- poeial requirements within a com- pany in order to plan and execute implementation and help ensure ongoing compliance (see Sidebar, pp. 30–35, Figures 1–2). This activity also provides an opportunity to influ- ence the compendial requirements through comments submitted in response to proposed revisions. The number of individual compendial changes to be reviewed for poten- tial impact to a company is stagger- ing: more than 3000 new or revised monographs and general chapters per year in the global pharmacopoe- ias alone. This number increases as a company scales up to bring addi- tional national pharmacopoeias into the process. Considering this large volume of work, the crucial decisions to be made are which pharmaco- poeias and which part of the revi- sion process a company will monitor. These decisions on the scope of com- pendial affairs activities may differ for different companies. T h e f i r s t d e c i s i o n — w h i c h pharmacopoeias to monitor—is dependent on where the compa- ny's products are registered and distributed. For a large multi-na- tional company with globally dis- tr ibuted produc ts, sur veillance of the global pharmacopoeias— European Pharmacopoeia (Ph. Eur.), British Phar macopoeia (BP), and United States Pharmacopeia–National For mular y (USP – NF ) —would be necessary, along with monitoring several of the important national pharmacopoeias, including the Japanese Pharmacopoeia ( JP) and those in China, Russia, and India. For a smaller bio/pharmaceutical company focused on products in clinical development, surveillance of only Ph. Eur. and USP–NF may be sufficient to remain compliant. The second decision—whether to follow proposed and/or official revi- sions—depends on several factors such as company resources, com- mitment to advocacy, and conscious choices to be proactive or reactive to achieve compliance. Some com- panies only follow official revi- sions to reduce the burden of the compendial process. Monitoring and implementing only pharmaco- poeia changes that are official is the minimum a company must do to comply with current requirements. Following both proposed and offi- cial changes allows a company the opportunity to be more proactive, potentially influencing the out- come of a proposal through advo- cacy. Either approach is acceptable and will allow a company to com- ply; however, following only official items drives the company to be more reactive, potentially making them ill-prepared when implementing the changes that occur. The challenges of monitoring proposed and official revisions pub- lished by global and national phar- macopoeias can make it difficult to achieve on-time compliance with updated requirements. This situation is further complicated by complex global supply chains in the bio/phar- maceutical industry, including mul- tiple manufacturing sites, external manufacturing sites, and excipient/ component suppliers that may be impacted by updated pharmacopoeia requirements. Based on the experi- ence of one of the authors, to address these challenges, a large multi-na- tional company assembled the com- pendial affairs group and a wide range of impacted stakeholders in an international, cross-divisional, multi- site, multi-day Kaizen event with the specific aim of mapping the existing process for compendial review and implementation to identify possi- ble improvements. This enabled the company to develop a new process for pharmacopoeia surveillance that emphasized monitoring phar- macopoeia revisions starting at the proposal stage, stressed the impor- tance of a comprehensive tracking tool, and created new cross-func- tional teams to assist in the impact assessment for the company. The enhanced process was more effec- tive, efficient, and sustainable in helping to ensure ongoing compli- ance with new and revised pharma- copoeial requirements. INDUSTRY SURVEILLANCE PROCESS: PEOPLE As noted earlier, the industry's sur- veillance of pharmacopoeia revi- sions is comprised of processes, people, and tools. Throughout the detailed description of the pro- cess (see Sidebar), the key players have been identified, and what emerges is the broad network that is required to accomplish this work. It is helpful to focus briefly on the people involved in an effective sur- veillance process, as follows: • Compendial affairs group • Internal stakeholders/subject matter experts (SMEs)/teams • L o c a l c o n t a c t g r o u p / In-country partners Regulatory Sourcebook Pharmacopoeia Compliance Series

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