Issue link: https://www.e-digitaleditions.com/i/1192284
36 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m poeia authority or a specific scientific liaison in the phar- macopoeia organization. The file is usually submitted in portable document format (PDF) with electronic signature to maintain the integrity of the file, which also serves as the official record of the company's position on the par- ticular issue. Some pharmacopoeias have online platforms that allow comments to be directly uploaded to that site. It is expected that other pharmacopoeias will follow suit in the coming years. Also, it is recommended that the tracking system, mentioned before, be configured so that submitted comments can be tracked to enable follow-up as needed. This also allows a determination of whether the comments and suggested changes submitted by a company were taken into account in the official version for implementation. This also provides the compendial affairs function with the abil- ity to generate metrics on the company's efforts to inf luence the pharmacopoeia authorities. 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. The last essential tool for a compendial affairs program is a global change control system. Items that are published as official by the pharmacopoeias typically have a six-month window for implementation from the time of publication. It is important that all appropriate functional areas within a company assess the impact and determine the implementa- tion steps for the site or global function. Key to the change process is a regulatory impact assessment to determine if any product registrations need to be updated. A simple change in a monograph could still result in updates to reg- istrations in several countries, determined by a company's filing strategies. To have an effective change control process that drives on-time implementation of a pharmacopoeia change, each site or global function must understand their role and execute it promptly. Also, a responsible person or group needs to be identified that will drive the change control from start to finish. This is a difficult job for multi- site, multi-product changes, or changes that impact mul- tiple registrations. It is important for the responsible person to begin this process shortly after the proposal has been reviewed. If a company begins the implementation process when an item is reviewed at the proposal stage, it will have done most of the assessment and planning before the item becomes official, when there is only six months to complete the implementation (see Sidebar, Figure 3). Taken together, the tools supporting the compendial pro- cesses can potentially identify emerging trends for each of the pharmacopoeias. The trends are identified by reviewing items in the compendial tracking and change control sys- tems and can then be molded to ref lect changes that should be made to existing development and commercial product support processes helping to ensure compendial line-of- sight (CLOS) for the company. Measuring success: Advocacy and compliance Management will often request a report of metrics regard- ing on-time completion of items for commenting and for implementation. Having described the details of the indus- try surveillance process, including the people and tools that are necessary, it is appropriate to ask how to measure success for this work. As it turns out, this can be somewhat difficult to do. Pharmacopoeia revisions take place over protracted periods of time. It typically takes a minimum of 18 months from proposal to official, and often much longer—up to sev- eral years for some major changes—for the pharmacopoe- ial revision process to be completed. Because of this, many changes remain open for a long time and the compendial affairs function may have hundreds of items that have not reached the final step in the process. In the end, however, success can be examined from the standpoint of advocacy and compliance. Advocacy. In monitoring pharmacopoeia revisions, a man- agement decision is required on whether the company will be proactive through advocacy efforts or strictly reactive in compliance. Advocacy is aimed at inf luencing the deci- sions of the pharmacopoeia authorities to impact the official content published in new editions and supplements. In ad- vocating for changes to revisions that have been proposed by the pharmacopoeia, there are very few quick wins. For people who have been involved in this work, it is often the case that advocacy does not consistently achieve its intended goal. Rarely are all comments submitted by a company ac- cepted by the pharmacopoeia, to be ref lected in the official requirements. A reasonable goal is to nudge the proposal in a meaningful way, hopefully inf luencing the major issues that have been identified, while accepting that minor issues may go unresolved. For their part, the pharmacopoeias must consider all comments received from stakeholders, who may have perspectives that are diverse and even contradictory. The pharmacopoeia authority balances this information to determine how best to proceed. Another aspect of advocacy is how a company reacts when comments are not accepted by the pharmacopoeia authority. The company can contact the appropriate scientific liaison at the pharmacopoeia to ensure the comments were clear and understood. Having established connections with the scientific staff in the pharmacopoeias can facilitate these discussions. Any unresolved issues that appear in the of- Pharmacopoeia Compliance Series