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Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 35 fairs activities, regardless of which functional group within the company has the responsibilities. Compendial affairs activities. The series began by providing the legal and regulatory basis that make pharmacopoeia com- pliance a requirement (1). To meet this obligation, an end-to- end framework was described that conveyed the internal and external difficulties in complying (2). The lack of harmonized standards increases the complexity of compliance (3–5). The decisions made by a company define the strategy and enable the execution of that strategy by the functional area desig- nated with oversight of the compendial affairs responsibili- ties. The responsible group, represented by the large yellow circle in Figure 1, would ensure all internal stakeholders are connected to the established processes and understand the impact their area has on the overall effort to ensure compli- ance. Management support across the company is essential for the compendial affairs function. This includes assurance that sufficient resources are available within a central function and from contributing or impacted departments to execute the company's established processes. Compliance. The critical outcome from the compendial af- fairs function is compliance (orange bubble in Figure 1). To help achieve this, two articles focused on the details of the pharmacopoeia revision process and the industry surveillance process that enable implementation of compendial changes needed for a company's compliance (6,7). The compendial affairs function must develop the appropriate tools that allow quick access to project status, ongoing communications, ex- pected next steps, and the generation of metrics usually re- quested by management to measure success. The compendial affairs function needs management commitment to ensure the accountability of the people throughout the company as- signed to execute the processes effectively and efficiently to maintain compliance. Case studies were presented to demon- strate why the compendial affairs function must establish and maintain strong internal partnerships across the company to ensure the established processes run well (10,11). Advocacy. The significant opportunity for the compendial affairs function is advocacy (green bubble in Figure 1). The decision a company makes on advocacy efforts is an im- portant part of its compendial affairs strategy, determining whether the organization will be proactive or reactive in their interaction with the pharmacopoeia authorities. A company can choose to participate in the development of monographs, comment on draft proposals, and join teams to elaborate or revise general chapters. Alternatively, a company may choose to have no advocacy role and only to implement the updated requirements that appear in official pharmacopoeia publica- tions. This decision has a significant impact on the resources needed for the compendial affairs function and from other impacted areas to support a company's established compen- dial processes. Teamwork • Compendial End-to-End Process (C-E2E) • Compendial Line-of-Sight (C-LOS) Scope Compliance Advocacy Compendial Affairs Activities • External Partnerships (Pharmacopoeia, Industry) • Monograph Development • Compendial Responses • Compendial Surveillance (Review: Proposals, Official) • Implementation Planning • Internal Partnerships Global Pharmacopoeias • USP, Ph. Eur., BP National Pharmacopoeias • JP, ChP, SP RF, FBras, KP, IP Figure 1. Compendial affairs function: Roles, responsibilities, activities, considerations. USP is United States Pharmacopeia. Ph. Eur. is European Pharmacopoeia. BP is British Pharmacopoeia. JP is Japanese Pharmacopoeia. ChP is Chinese Pharmacopoeia. SP RF is Russian Pharmacopoeia. FBras is Brazilian Pharmacopoeia. KP is Korean Pharmacopoeia. IP is Indian Pharmacopoeia. ALL FIGURES COURTESY OF THE AUTHORS.