Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 17 of 43

18 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series It is helpful to consider these designations in more detail (see Sidebar on pages 22–23). Throughout these articles, the European Pharmacopoeia (Ph. Eur.), British Pharmacopoeia (BP), and United States Pharmacopeia–National Formulary (USP–NF) are considered global pharmacopoeias, based on their acceptance by regulators around the world. Many other important pharmacopoeias are considered national. Revision process for global pharmacopoeias In their article (6), Schwarzwalder and Bishara made the critical point, "… pharmacopoeial requirements are not static, and continued compliance demands that companies in this regulated industry be alert to changes." The article continues, "(a) program for reviewing pharmacopoeial proposals and implementing changes is needed to ensure continued compliance." Surveillance activities used by bio/pharmaceutical com- panies are triggered by the publication of new and revised pharmacopoeial requirements. The publication schedule, in turn, is driven by the pharmacopoeia revision process. The ongoing revision of pharmacopoeias can be initiated in several ways. For example, pharmacopoeia changes can be driven by a significant technology update that requires a general chapter to be revised. Changes could be started to ref lect a new International Council for Harmonization (ICH) guidance (e.g., Q3D) with impact to both existing general chapters and to monographs for many materials. Pharmacopoeial updates may be driven by collaborative efforts to achieve harmonization, as with the activities of the Pharmacopoeial Discussion Group (PDG), which is comprised of representatives from the Ph. Eur., USP, and the Japanese Pharmacopoeia (JP). Pharmacopoeial evolu- tion can be sparked by industry with the submission of a new or revised monograph. With so many possible avenues for change, the situation clearly demands that a company have a process for monitoring and staying up to date with the continuous revisions in the pharmacopoeias. But obvi- ously, monitoring is not enough, since impact assessment and change control are needed to enable ongoing compli- ance with the current requirements. These considerations will be discussed in later articles. The revision process used by global pharmacopoeias in- cludes internal steps taken by the responsible organization and authorities, and also has steps that connect with exter- nal stakeholders (e.g., the bio/pharmaceutical industry and health authorities) that may be impacted by the changes (7, 8). Figure 1 shows the process steps followed to generate a pro- posal for a new or revised monograph or general chapter, and the subsequent steps to move the proposed update to official status. At the outset, the governing body of the phar- macopoeia—called the Commission for Ph. Eur. and BP, and the Convention for USP—defines its strategic direction and Pharmacopoeia Process Strategic direction and proposed workplan established by pharmacopoeia governing body Pharmacopoeia receives requests for new and revised monographs and general chapters Pharmacopoeia expert group determines whether to proceed with requested update Development of new/revised monograph/general chapter proceeds. Draft proposal is prepared Proposal published for public review/comments Expert group considers comments. Determines next step (move to official, further revise, cancel) Commission/expert group approves update to become official Official update published in new edition or supplement for implementation by stakeholders Stakeholder Input Commission/Convention establishes expert groups, which are comprised of stakeholders Request for updates submitted by stakeholders (Industry, Health Au- thorities, Pharmacopoeia, etc.) Stakeholders provide comments on proposals Figure 1. Pharmacopoeia revision process. FIGURES COURTESY OF THE AUTHORS.

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