Issue link: https://www.e-digitaleditions.com/i/1193175
32 BioPharm International eBook December 2019 www.biopharminternational.com company mentioned in the main article that held the Kaizen event, the improved procedure created a new team, called the "central triage team", to meet on a regular (bi-weekly) basis and assess each individual compendial change published during that time period to determine those with the greatest potential impact. As suggested by the name, this team is comprised of representatives from central functions within the company, including: compendial affairs; quality control/assurance; external quality assurance; regulatory/chemistry, manufacturing, and controls (CMC); bio/ analytical sciences; 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. After the publication of a new edition or supplement (i.e., official 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 impact 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 specific 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, 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. Regulatory Sourcebook Pharmacopoeia Compliance Series Bio/pharmaceutical industry surveillance of compendial changes: Process in detail (cont.)