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38 BioPharm International eBook December 2019 www.biopharminternational.com Regulatory Sourcebook Pharmacopoeia Compliance Series can potentially identify emerging trends for each of the pharma- copoeias. The trends are identi- f ied by rev iew ing items in the compendial tracking and change control systems and can then be molded to ref lect changes that should be made to existing devel- opment a nd com merc ia l prod- uct support processes helping to ensure compendial line-of-sight (CLOS) for the company. MEASURING SUCCESS: ADVOCACY AND COMPLIANCE Management will often request a rep or t of met r ic s rega rd i ng on-time completion of items for commenting and for implementa- tion. Having described the details of the industry surveillance pro- cess, including the people and tools that are necessary, it is appropri- ate 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 pharmacopoeial 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 pharma- copoeia revisions, a management decision is required on whether the company will be proactive through advocacy efforts or strictly reac- tive in compliance. Advocacy is aimed at influencing the decisions of the pharmacopoeia authorities to impact the official content pub- lished in new editions and supple- ments. In advocating for changes to revisions that have been pro- posed by the pharmacopoeia, there are very few quick wins. For peo- ple who have been involved in this work, it is often the case that advo- cacy does not consistently achieve its intended goal. Rarely are all comments submitted by a company accepted by the pharmacopoeia, to be reflected in the official require- ments. A reasonable goal is to nudge the proposal in a meaning- ful way, hopefully influencing the major issues that have been iden- tified, 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 pharmaco- poeia authority balances this infor- mation to determine how best to proceed. Another aspect of advocacy is how a company reacts when com- ments are not accepted by the phar- macopoeia authority. The company can contact the appropriate scien- tific liaison at the pharmacopoeia to ensure the comments were clear and understood. Having established connections with the scientific staff in the pharmacopoeias can facil- itate these discussions. Any unre- solved issues that appear in the official revision can be the basis for the company to request a new revision to the general chapter or monograph, providing additional rationale or scientific data to sup- port the requested change. The advocacy part of the com- pendial process can be very reward- ing when comments are accepted by the pharmacopoeia authori- ties. It can be equally frustrating when sound scientific rationale may not be accepted, leaving a potential compliance gap for the company. It can be difficult to explain to company scientists and management that the comments were not accepted, and that pro- cedures and documentation may need to be changed to reflect the official requirements. Another frus- trating and challenging aspect of the compendial process may be encountered as a result of differ- ing timelines followed by the phar- macopoeias to make harmonized requirements official, as has been seen with the updated chapters on residual solvents and elemental impurities to align with the corre- sponding International Council for Harmonization (ICH) guidelines. Still, 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. Compliance. The ultimate goal of the industry surveillance process for monitoring pharmacopoeia revi- sions is to maintain ongoing com- pliance with current requirements, as expected by regulatory agencies around the world. The success of a company's process can be measured by on-time implementation of offi- cial pharmacopoeia revisions. 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.