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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 31 with potential impact to the company, essentially all new and revised chapters in a pharmacopoeia publication may need further assessment. Figure 2 depic t s the f iltering process used in monitoring pharmacopoeia revisions. A typical year may see the publication of 3000 or more total items that are new or revised in the global pharmacopoeias, which must be filtered. Using the lists of materials, products, and general chapters described previously, the compendial affairs function filters the TOC for each publication to identify items that may impact the company. For large multi-national companies, the initial TOC filter may identify approximately 500 items with potential impact. These constitute the set of items each year that may require change control when the items become of ficial. Following the TOC filter, the compendial affairs group or another specified function in the company then carries out a deeper dive to further filter the identified items and determine if they have major impact to the company. Pharmacopoeia updates with the greatest potential impact include the following: • New or significantly revised general chapters • New monographs including specifications/limits and methods, which may be different than the company's product registration • Revised monographs with changes to specifications/limits • Revised monographs with new or significantly updated methods, which may require new procedures, equipment, columns, or reagents • Changes that may impact labeling, packaging, storage, and/or distribution. This determination of major impact can be accomplished in several ways, but it is often true that input from multiple groups is required, because of the potentially broad impact of pharmacopoeia updates. A company may have the subject matter expert (SME) for the topic (general chapter) or material (monograph) review the change. In some cases, a specified group of company SMEs may review all changes and assess the potential impact. For the 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 af fairs; quality control/assurance; ex ternal quality assurance; regulator y/ chemistr y, manufac turing, and controls; bio/analy tical sciences; Bio/pharmaceutical industry surveillance of compendial changes: Process in detail (cont.) Pharmacopoeia Process Industry Surveillance Process Proposal Publication (Pharmacopoeia Forum) Comments Evaluated Official Publication (New Edition, Supplement) Request Evaluated Monitor Publication Filter for Impact Communicate Changes Evaluate Changes Plan for Implementation Prepare Response Monitor Publication Filter for Impact Communicate Changes Evaluate Changes Proceed with Implementation Revision Request Figure 1. Industry surveillance process steps. ALL FIGURES COURTESY OF THE AUTHORS