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www.biopharminternational.com March 2020 BioPharm International eBook 37 tinued supply of quality medicines to patients globally. PUTTING IT ALL TOGETHER Figure 1 presents a holistic view of the roles, responsibilities, activi- ties, and other considerations of the compendial affairs function, which a re necessa r y to ensure pharmacopoeia compliance across the bio/pharmaceutical industry. This fig ure captures four major areas that define a company's strat- egy and approach to determine its compendial affairs program. A suc- cessful program establishes many processes and maintains a series of complex internal and external partnerships to ensure a company can comply. The articles in this series touch on all four areas to provide guidance and clarity to companies struggling to set a strat- eg y or to improve their current processes. They also provide ratio- nale to support a business case to justify the people, processes, and tools necessary to enable compli- ance. The information can serve as the basis for standard operating procedures (SOPs) or work instruc- tions for compendial affairs activi- ties, regardless of which functional group within the company has the responsibilities. Compendial affairs activities The series began by providing the legal and reg ulator y basis that make pharmacopoeia compliance a requirement (1). To meet this obli- gation, an end-to-end framework was described that conveyed the internal and external difficulties in complying (2). The lack of har- monized standards increases the complexity of compliance (3–5). The decisions made by a company def ine the strateg y and enable the execution of that strategy by the f unc tional area desig nated w ith oversight of the compen- dial affairs responsibilities. The responsible group, represented by the large yellow circle in Figure 1, would ensure all internal stake- holders are connected to the estab- lished 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 contrib- uting or impacted departments to execute the company's established processes. Regulatory Sourcebook Pharmacopoeia Compliance Series 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 AUTHOR.