Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Page 18 of 43

Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 19 proposed workplan for the duration of the cycle, based on its own governing rules. For Ph. Eur., this is a three-year cycle, coinciding with the publication of each new edition. The ac- tivities of the BP Commission are reported annually, with a triennial review to provide assurance that they are operating effectively. For USP, the Convention is on a five-year cycle. The Commission or Convention establishes expert groups or committees that further refine the direction, focus areas, and specific workplans, which are used to identify, prioritize, and pursue key issues and gaps in compendial coverage (9). These expert groups are typically comprised of volunteers from industry, academia, healthcare, and government agen- cies, to ensure that a broad representation of stakeholders contribute to the process. The expert groups review sugges- tions received for new or revised items as possible updates to the pharmacopoeias. Suggestions for new general chapters or monographs and revisions to existing general chapters or monographs, with appropriate justification for the request, may come from various stakeholders such as industry, aca- demia, healthcare practitioners, and trade organizations, or may come from the pharmacopoeia expert groups or staff themselves. Proposals specifically for harmonized general chapters and excipient monographs may also come as a re- sult of the work of the PDG. Within the overall context of pharmacopoeia revisions, it is useful to realize that industry can inf luence this process through active collaboration and communication with the pharmacopoeias to make proposals for new and updated re- quirements. This inf luence will be explored in a later article that looks at the monograph submission process. Addition- ally, having a company's subject matter experts participate on an expert group is another excellent way to participate and inf luence the direction of new and revised pharmaco- poeial requirements. The request for a new or revised monograph or general chapter is reviewed by the appropriate pharmacopoeia staff and expert group to determine if it should proceed as a pro- posal for public review and comment. For Ph. Eur., input is obtained from the pharmacopoeia authorities in each Euro- pean member country on whether to add the requested up- date to the workplan. In progressing the work to develop the update, the pharmacopoeia expert group and staff may be assisted by advisory working parties or expert panels with technical knowledge on the particular subject. Additional information may be sought from the original submitter of the request, from other manufacturers, additional interested parties, or from specialists with knowledge in that particular area. Often, laboratory work is performed by the pharmaco- poeias, regulatory agencies, industry, or academia to support the proposal by verifying the suitability of analytical proce- dures and qualifying physical reference standards needed for the proposal. A draft of the proposal is prepared and published by the pharmacopoeia, usually through an on-line forum for public review and comment by stakeholders. The expert group considers any comments received and determines the appropriate next step in the process, which may be a recommendation to move the proposal forward as an official change, to make further revision to the proposal with pos- sible re-publication in the forum (if changes are significant), or to cancel the proposal. Responsibility for adoption or ap- proval of the proposal to move it to official status is given to the decision-making body of the pharmacopoeia. For Ph. Eur., the decision is made by the Commission and requires unanimous agreement. For USP, the decision is made by the expert group based on majority vote. Once adopted, the new or revised monograph or general chapter is published in the next edition or supplement to the pharmacopoeia and becomes official on the date specified for the update. It is at this point that companies must comply with the updated requirements. It is also at this point that a request for further revision to a monograph or chapter—or to any of the official requirements in the pharmacopoeia— may be submitted by a company or other stakeholder, with appropriate justification for the requested revision. This request would start the pharmacopoeia revision cycle over again from the beginning. While these ongoing updates provide an opportunity for advocacy, more importantly they stand as the fundamental reason why a company must monitor pharmacopoeia publications to remain compliant with the current requirements. Publication schedule for global pharmacopoeias As noted above, the pharmacopoeia revision process in- cludes two stages where information is made available to stakeholders: • Draft proposals for new and revised monographs and general chapters • Updates to official requirements. This information is provided by the pharmacopoeias through two types of publications and online postings: • Proposals are communicated through a pharmacopoeia forum, which provides stakeholders the opportunity to comment on the new or revised item • Official updates to general chapters and monographs are published in new editions and supplements to the phar- macopoeia. All stakeholders are expected to implement the updated official requirements in the timeframe specified by the pharmacopoeia. These updates stand as the fundamental reason why a company must monitor pharmacopoeia publications to remain compliant.

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