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16 BioPharm International eBook December 2019 www.biopharminternational.com T h e r e v i s i o n p r o c e s s u s e d b y g l o b a l p h a r m a c o p o e i a s i nc lud e s i nte r n a l s te p s t a ke n by the responsible organization a nd aut hor it ie s, a nd a l s o ha s steps t hat con nec t w it h e xter- na l sta keholders (e.g., t he bio/ p h a r m a c e ut ic a l i n d u s t r y a n d health authorities) that may be impacted by the changes (7, 8). Figure 1 shows the process steps followed to generate a proposal for a new or revised monograph or general chapter, and the sub- sequent steps to move the pro - posed update to official status. At the outset, the governing body of the phar macopoeia— called the Commission for Ph. Eur. and BP, a nd t he C onvent ion for USP — defines its strategic direction and proposed workplan for the dura- tion 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 activities of the BP Commission are reported annu- ally, w ith a triennial rev iew to provide assurance that they are operat i ng ef fec t ively. For USP, t he C onve nt ion i s on a f ive - year c ycle. T he Commission or C onvent ion est abl ishes e x p er t g roups or committees that f ur- ther refine the direction, focus a rea s, a nd sp e c i f ic work pla ns, which are used to identif y, pri- or it i ze, a nd pu r sue key issues and gaps in compendial cover- age (9). These expert groups are typically comprised of volunteers from industry, academia, health- care, and government agencies, to ensure that a broad represen- tation of stakeholders contribute to the process. The expert groups rev iew suggestions received for new or revised items as possible up d ate s to t he ph a r m acop o e - ias. Suggestions for new general chapters or monographs and revi- sions to existing general chapters or monog raphs, w ith appropr i- ate justification for the request, may come f rom va r ious sta ke - holder s suc h a s i ndust r y, ac a- demia, healthcare practitioners, and trade organizations, or may come f rom t he pha r macopoeia expert groups or staff themselves. Proposals specifically for harmo- nized general chapters and excip- ient monographs may also come as a result of the work of the PDG. Within the overall context of pharmacopoeia revisions, it is use- f ul to realize that industr y can inf luence t his process t hrough ac t ive col lab orat ion a nd com- mu n ic at ion w it h t he pha r ma- copoeias to make proposals for FIGURES COURTESY OF THE AUTHORS Regulatory Sourcebook Pharmacopoeia Compliance Series Figure 1. Pharmacopoeia revision process. 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