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36 BioPharm International eBook December 2019 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series ity to identif y all changes with potential impact and to be more successful in the resulting advo- c ac y e f for t s . D u r i n g t he pr o - posal stage, through discussions i n t he i nd u s t r y a s s o c i at io n s , it is often found that the com- pendial affairs f unction in one company has identified a poten- tially major revision, when other c o mp a n ie s m ay no t y e t h ave made t hat deter minat ion. T his he ig hte ne d aw a r e ne s s e n able s g reater assu ra nce t hat a major cha nge is not m issed, a nd t he resulting discussion can focus on how the change may impact the broader industry. If the particular i ndust r y g roup cha r ter a l lows, a nd t he proposed cha nge wa r- rants, comments can be sent to t he pha r macopoeia aut hor it ies by the association, representing the input of many companies to bring added weight to any con- c e r n s ide nt i f ie d . A ga i n, t he s e com ments need to be sc ient i f- ica l ly ba sed a nd supp or ted by data where appropriate. Being connec ted to industr y trade organizations is invaluable in these sit uations because the organization represents compa- nies that have similar opinions. For high-impact changes, such as elemental impurities, it is import- ant to have this connection to trade organizations to help con- sol idate t he i ndust r y poi nt of view. Leveraging this critical mass through comments to proposals can influence the final outcome of the official revision. Investing time to participate in these organi- zations is a simple yet effective way to leverage the power and influ- ence they have when engaging with the pharmacopoeias. For their part, the pharmacopoeia authori- ties have demonstrated their will- ingness to engage with industry to discuss issues that are identified. INDUSTRY SURVEILLANCE PROCESS: TOOLS The final piece of the industry sur- veillance process is focused on the tools that help the compendial activ- ities run smoothly and enable the people to remain actively engaged. This piece of the puzzle is as crucial as the process and people in ensur- ing a compliant system. Investing in appropriate tools allows for compre- hensive tracking, ease of communi- cation, implementation of revisions, and generation of metrics on the effectiveness of the process. The most important tool for a compendial affairs program is the one to track the pharmacopoeia changes identified with impact to the company and the current sta- tus of these items. The tracking can be done using various tools, from a simple spreadsheet/database or a SharePoint (Microsoft) 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 pro- gram, an approach of "crawl, walk, run" can be applied. At the begin- ning, the process may use a simple spreadsheet to track items of interest. As the program matures and the pro- cesses become more defined, a data- base or a SharePoint team site may be appropriate. The latter offers an opportunity to add automatic noti- fications 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 application will allow for the connection of proposal items and official items to help aid the assess- ment and change control processes needed for compliance. Other tools critical to the success of compendial surveillance 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 com- pany. The challenges of trying to pull all the necessary information on materials used, where they are used, and if they are still active are significant. Rarely is a single sys- tem available to accomplish this; rather, it requires the aggregation of information from multiple systems throughout the company. Requests may need to go to the various busi- ness systems across a company with the resulting information combined into one list by the compendial affairs function to ensure all mate- rials are captured for the filtering process. This is a time-consuming and people-intensive process step, but it may be the only approach to ensure all materials are captured for a company, in the absence of a single, integrated business system. Another important determination is which general chapters need to be assessed by a company. Investing the time to develop a grid of "similar" chapters across the pharmacopoe- ias and which general chapters are used by the company will ensure a Being connected to industry trade organizations is invaluable because the organization represents companies that have similar opinions.