Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 27 pharmacopoeias and participation in industry trade associa- tion activities provide other avenues for advocacy and shar- ing of best practices and perspectives on compendial issues. In this role, the individuals in compendial affairs also serve as the single point of contact (SPOC) in interactions with the pharmacopoeias. Finally, the compendial affairs group should serve as the internal support for the entire company, providing knowledge and experience in all things related to the pharmacopoeia. Considering the numerous responsibilities listed above, each company's approach to resourcing the compendial af- fairs function can be very different. Benchmarking of the bio/ pharmaceutical industry revealed that some major multi- national companies have three to five full-time employees in a compendial affairs role. The more common approach, however, is that a single individual or a couple of individuals with part-time responsibility comprise the compendial affairs functions. Of course, the fewer the resources available in a company's compendial affairs function, the more challeng- ing it becomes to consistently carry out all the responsibili- ties necessary to ensure ongoing compliance. One company utilizes an outsourcing model for monitoring pharmacopoeia revisions, establishing a SPOC in the company to manage the surveillance process that is carried out by external contractors. This approach can reduce the cost of using internal resources for that part of the effort, which is considered largely adminis- trative. The external team can execute the review and filtering process and then assign the identified items with potential im- pact to a company's internal groups for complete assessment. The first decision—which pharmacopoeias to monitor— is dependent on where the company's products are registered and distributed. Another consideration is where within a company the com- pendial affairs function should reside (1). Key to this organi- zational decision is realizing that many functional areas in a company may be impacted by pharmacopoeial requirements. In one sense, it can be argued that compendial affairs could fit anywhere within a company, while the practical reality is that this function does not seem to fit well anywhere. Benchmark- ing has shown compendial affairs to be organized within the quality, regulatory, or research and development functions, or even at a corporate level due to the broad impact. There is no right or wrong organizational approach, but the key con- sideration is that compendial affairs functions are critical to ongoing compliance. The individuals or group assigned these responsibilities need to have management support across the company to effectively address the impact of pharmacopoeia revisions, ensuring the necessary tasks are assigned the ap- propriate priority. Industry surveillance process: Purpose and scope Perhaps the most important of the compendial affairs re- sponsibilities is surveillance of pharmacopoeial revisions. A detailed description of the industry surveillance process is provided in the Sidebar to this article. The purpose of this surveillance is to identify, communicate, and enable as- sessment of the potential impact resulting from updates to pharmacopoeial requirements within a company in order to plan and execute implementation and help ensure ongoing compliance (see Sidebar, pp. 30–35, Figures 1–2). This activity also provides an opportunity to inf luence the compendial requirements through comments submitted in response to proposed revisions. The number of individual compendial changes to be reviewed for potential impact to a company is staggering: more than 3000 new or revised monographs and general chapters per year in the global pharmacopoe- ias alone. This number increases as a company scales up to bring additional national pharmacopoeias into the process. Considering this large volume of work, the crucial decisions to be made are which pharmacopoeias and which part of the revision process a company will monitor. These decisions on the scope of compendial affairs activities may differ for dif- ferent companies. The first decision—which pharmacopoeias to monitor—is dependent on where the company's products are registered and distributed. For a large multi-national company with globally distributed products, surveillance of the global phar- macopoeias—European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP), and United States Pharmacopeia–Na- tional Formulary (USP–NF)—would be necessary, along with monitoring several of the important national pharmacopoe- ias, including the Japanese Pharmacopoeia (JP) and those in China, Russia, and India. For a smaller bio/pharmaceutical company focused on products in clinical development, sur- veillance of only Ph. Eur. and USP–NF may be sufficient to remain compliant. The second decision—whether to follow proposed and/or official revisions—depends on several factors such as com- pany resources, commitment to advocacy, and conscious choices to be proactive or reactive to achieve compliance. Some companies only follow official revisions to reduce the burden of the compendial process. Monitoring and imple- menting only pharmacopoeia changes that are official is the minimum a company must do to comply with current re- quirements. Following both proposed and official changes allows a company the opportunity to be more proactive, potentially inf luencing the outcome of a proposal through advocacy. Either approach is acceptable and will allow a com- pany to comply; however, following only official items drives the company to be more reactive, potentially making them ill-prepared when implementing the changes that occur.

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