Issue link: https://www.e-digitaleditions.com/i/1192284
Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 29 All the groups mentioned are internal to a company, but the discussion of people that support the surveillance pro- cess is not complete without consideration of a key external connection: pharmaceutical industry associations. These associations may be found in many countries and regions around the world and a list of some key industry groups that monitor the pharmacopoeias are included in Table I. The value gained by a company through connecting with the compendial interest or discussion groups in these indus- try associations should not be underestimated. It should be noted that these groups do not talk about pharmacopoeia changes that impact only one or a few companies, such as specific monographs for drug products or ingredients. Rather, the focus of their discussion is on changes that have broader impact to the entire industry, as seen with general chapters, which are used by many companies. Key benefits of engaging with industry groups include recognizing you are not in this alone; that it is helpful having many eyes look at the information; and there is power in numbers. Participating in these groups as part of the compendial process increases a company's ability to identify all changes with potential impact and to be more successful in the re- sulting advocacy efforts. During the proposal stage, through discussions in the industry associations, it is often found that the compendial affairs function in one company has identified a potentially major revision, when other com- panies may not yet have made that determination. This heightened awareness enables greater assurance that a major change is not missed, and the resulting discussion can focus on how the change may impact the broader industry. If the particular industry group charter allows, and the proposed change warrants, comments can be sent to the pharmaco- poeia authorities by the association, representing the input of many companies to bring added weight to any concerns identified. Again, these comments need to be scientifically based and supported by data where appropriate. Being connected to industry trade organizations is in- valuable in these situations because the organization repre- sents companies that have similar opinions. For high-impact changes, such as elemental impurities, it is important to have this connection to trade organizations to help con- solidate the industry point of view. Leveraging this criti- cal mass through comments to proposals can inf luence the final outcome of the official revision. Investing time to par- ticipate in these organizations is a simple yet effective way to leverage the power and inf luence they have when engaging with the pharmacopoeias. For their part, the pharmacopoeia authorities have demonstrated their willingness to engage with industry to discuss issues that are identified. Industry surveillance process: Tools The final piece of the industry surveillance process is fo- cused on the tools that help the compendial activities run smoothly and enable the people to remain actively engaged. This piece of the puzzle is as crucial as the process and peo- ple in ensuring a compliant system. Investing in appropriate tools allows for comprehensive tracking, ease of commu- nication, implementation of revisions, and generation of metrics on the effectiveness of the process. The most important tool for a compendial affairs pro- gram is the one to track the pharmacopoeia changes identi- fied with impact to the company and the current status of these items. The tracking can be done using various tools, from a simple spreadsheet/database or a SharePoint (Mi- crosoft) team site with simple functionality to a specially configured out-of-the-box quality solution or a customized in-house system specifically designed for tracking. Each of these options have been used by a number of companies and are viable solutions to enable proper tracking of the compendial process. As a company works to establish a compendial affairs program, an approach of "crawl, walk, run" can be applied. At the beginning, the process may use a simple spreadsheet to track items of interest. As the pro- gram matures and the processes become more defined, a database or a SharePoint team site may be appropriate. The latter offers an opportunity to add automatic notifications and due-date reminders for assessment tasks. It also allows for export of the data to enable metrics (monthly, quarterly, or annually) to be generated. If configured properly, the ap- plication will allow for the connection of proposal items and official items to help aid the assessment and change control processes needed for compliance. Being connected to industry trade organizations is invaluable because the organization represents companies that have similar opinions. Other tools critical to the success of compendial surveil- lance were mentioned in the filtering stage of the detailed process (see Sidebar): the lists of drug products and related materials, including pharmacopoeia general chapters used by a company. The challenges of trying to pull all the nec- essary information on materials used, where they are used, and if they are still active are significant. Rarely is a single system available to accomplish this; rather, it requires the aggregation of information from multiple systems through- out the company. Requests may need to go to the various business systems across a company with the resulting in- formation combined into one list by the compendial affairs function to ensure all materials are captured for the filter- Contin. on page 35