Issue link: https://www.e-digitaleditions.com/i/1192284
32 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series microbiology; and stability. For a large multi-national company, as many as 100 new or revised items per year may be identified in pharmacopoeia updates with potentially major impact. Whichever way the surveillance process is designed, this triage step to assess major impact is important because it will allow more resources to focus on these changes, reflecting the complexity and urgency needed. The remaining items identified—400 in this example (Figure 2)—will fall to the minor or no impact category and require further assessment to determine if they can be closed with minimal additional input from the business. For national pharmacopoeias, as mentioned earlier, it is important to have a connection with the local contact group in that country. Af ter the publication of a new edition or supplement (i.e., of f icial changes), or forum (i.e., draft proposals for comments), the local group would perform the TOC filtering of items based on the drug products registered and distributed in that country. The list of affected materials or general chapters could be smaller than the global lists for the entire company. If there are products or formulations specific to that market, any unique excipient, API, or drug product monograph needs to be identified and added to the local filtering list. The determination of major impac t for these items in the national pharmacopoeias can be accomplished by the local contact group or via the process established for items found in the global pharmacopoeia publications. Communicate the changes. Once the specif ic materials and general chapters of interest to a company have been identified, an in-depth assessment is needed for the specific changes, with tasks assigned to the appropriate SME or business function. The notification of pharmacopoeia updates to a company's impacted stakeholders may be provided individually, with each change sent to the specific SMEs for assessment, or as a compilation of all the changes identified in a particular pharmacopoeia publication or over an established time period. Some companies use both approaches—individual notification and a consolidated list—to ensure visibility and awareness for a wide range of stakeholders, and to increase the chances that all functional areas have an opportunity to consider the potential impact of the changes. A key part of this communication is determining who in the company needs to receive the information, as well as what tool is used for notification and monitoring the tasks. The compendial affairs function needs to establish the list of SMEs to review/assess each new and revised item found during the filtering step of the process. This is not an easy task, because SMEs reside in multiple functions across a company (e.g., quality, regulatory, analytical, research and development, supply chain, packaging development, labeling, logistics for distribution, and external manufacturing). Once established, the list of SMEs needs to be maintained with updates to reflect turnover in personnel and changes in responsibilities for these areas. Maintaining the engagement and commitment of the SMEs is also challenging, but crucial to the success of the surveillance process. When the compendial affairs function requests assessment of pharmacopoeia updates by SMEs from the business Bio/pharmaceutical industry surveillance of compendial changes: Process in detail (cont.) United States Pharmacopeia European Pharmacopoeia British Pharmacopoeia • More than 30 publications/website postings per year Filter: TOC Filter: Major Impact Filter: Minor Impact >3000 Total Items for Review ~500 Items with Potential Impact / Possible Change Control 400 Items with Minor/No Impact 100 Items with Major Impact 100 Items with Minor Impact 300 Items with No Impact Figure 2. Surveillance process: Filtering global pharmacopoeia publications for impact.