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36 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m Advocacy approaches were explored in several articles that focused on monograph development, compendial responses, and external partnerships with bio/pharmaceutical trade organizations. The deep-dive into the advocacy processes highlighted the pros and cons of choosing to participate or not. A list was provided of several external organizations a company can join to enable open discussions and to leverage their responses on issues with broad impact (7). The effec- tiveness of an organization's advocacy is a critical part of their compendial success. If a company submits comments on proposals that are adopted by the pharmacopoeia, it may be easier for the company to implement the official revision than it would have been if no comments had been submit- ted. A roadmap was provided to help a company define its strategy for the important advocacy effort of monograph development: why and when to participate with the phar- macopoeia authorities (8). The operational aspects of who in the company should own monograph submissions, how to participate, and how to achieve harmonized monographs were also explored (9). The details presented in these articles provide the basis for a checklist that a company can utilize if it decides to proactively engage in monograph development. Scope. A company needs to decide which pharmaco- poeias are in scope for their compendial affairs program (purple bubble in Figure 1). To assist in this determination, one article presented the history of the pharmacopoeias and how they have evolved over time, especially in the past 200 years (3). A common thread was highlighted, that the formation of a new pharmacopoeia was historically driven by the need for consistent standards that ensured patients received high-quality medicines. The case was made for to- day's need for global harmonization of the standards in the pharmacopoeias to benefit global patients (4). The inconsis- tency of the standards adds extra work and complexity for a company to comply. An aspirational goal of a "world where there is no need for translation" was introduced as the ulti- mate outcome of any global harmonization activities (4,12). The current state of harmonization activities was discussed, including efforts by the Pharmacopoeial Discussion Group (PDG) and the International Council for Harmonization (ICH), as well as the concept of prospective harmonization, which ref lects a partnership between the industry and phar- macopoeias and is supported by the Good Pharmacopoeial Practices guidance (5,13). Definitions for global and national pharmacopoeias were provided (6) to help an organization define which pharmacopoeias are in scope for their sur- veillance processes. The breadth of the compendial affairs program is directly related to the decision made by a com- pany of which pharmacopoeias will and will not be reviewed. Teamwork. Throughout the articles, the authors referred to the people, processes, and tools needed for the compen- dial affairs activities. Teamwork within the organization (blue bubble in Figure 1) is the most critical aspect to ensure efficient processes and successful outcomes for a central compendial affairs function. The need for cross-functional support within the company was specified as critical to en- suring the success of a specific process. Without teamwork, advocacy efforts to comment on proposals or to implement an official revision to remain compliant will not happen. It is critical that the company develop an end-to-end perspec- tive to maintain compendial line-of-sight, understanding how the efforts of every part of the organization affect the outcomes that are achieved. The entirety of the compen- dial processes become almost impossible to sustain without teamwork in an organization. In summary, the ultimate objective of these articles was to provide a thorough understanding of compendial challenges and opportunities for those involved in the work, and to help educate others in their company on the importance of the activities. The articles contribute ideas and suggestions to help companies avoid recreating the wheel and assist in developing best practices for bio/pharmaceutical compa- nies to ensure compliance with compendial and regulatory requirements. Meeting these compliance goals enables on- time delivery of high-quality medicines for patients around the world, fulfilling the mission of every health authority and pharmacopoeia, as well as the entire bio/pharmaceu- tical industry. What is on the horizon New regulations emerge, existing regulations change, and un- expected problems arise that require all stakeholders to evolve, including the pharmacopoeia. Schwarzwalder and Bishara (14) described this constant evolution, pointing out that a compendial affairs function must look at potential changes that are being evaluated by the pharmacopoeia authorities for implementation in the future. As noted in a previous article in this series (6), there are many reasons that can spur changes to the pharmacopoeia. Some additional examples include: • Contamination issues, such as glycerin contaminated with diethylene glycol (15), heparin contaminated with oversulfated chondroitin sulfate (16), or nitrosa- mines found in sartans, a class of drug products used to treat high blood pressure (17). Each incident has led to significant safety concerns, with new tests and con- trols being added by the pharmacopoeia. • Continuing harmonization efforts between global and national pharmacopoeias. Pharmacopoeia Compliance Series New regulations emerge, existing regulations change, and unexpected problems arise that require all stakeholders to evolve, including the pharmacopoeia.