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www.biopharminternational.com eBook December 2019 BioPharm International 17 new and updated requirements. This inf luence will be explored in a later article that looks at the monograph submission process. Additionally, having a company's subject matter experts participate on a n exper t g roup is a not her excellent way to participate and inf luence the direc tion of new a n d r e v i s e d p h a r m a c o p o e i a l requirements. The request for a new or revised monog raph or genera l chapter is rev iewed by t he appropr iate pharmacopoeia staff and expert group to determine if it should proceed as a proposal for pub - lic review and comment. For Ph. Eur., input is obtained from the ph a r m ac op o e i a aut hor it ie s i n each European member country on whether to add the requested update to the workplan. In pro- gressing the work to develop the update, the pharmacopoeia expert group and staff may be assisted b y a d v i s o r y w o r k i n g p a r t i e s or expert panels with technical knowledge on the particular sub- ject. Additional information may be sought from the original sub- mitter of the request, from other manufacturers, additional inter- ested parties, or from specialists with knowledge in that particu- lar area. Often, laboratory work is performed by the pharmacopoe- ias, regulatory agencies, industry, or academia to support the pro- posal by verifying the suitability of analytical procedures and qual- if y ing physica l reference sta n- dards needed for the proposal. A draft of the proposal is pre- pared and published by the phar- macopoeia, usually through an on-line forum for public review a n d c o m m e n t b y s t a k e h o l d - e r s. T he e x p e r t g roup con sid- ers any comments received and determines the appropriate next step in the process, which may be a recommendat ion to move the proposal forward as an offi- c i a l c h a n ge, to m a ke f u r t he r rev i sion to t he prop os a l w it h p ossible re -publ ic at ion i n t he for u m (i f c ha nges a re sig n i f i- cant), or to cancel the proposal. R e s p o n s i b i l i t y f o r a d o p t i o n or approva l of t he proposa l to move it to official status is given to t he d e c i s io n - m a k i n g b o d y of t he pha r macopoeia. For Ph. Eur., the decision is made by the Commission and requires unan- imous ag reement. For USP, t he decision is made by the exper t group based on majority vote. O n c e a d o p t e d , t h e n e w o r rev ise d monog raph or ge ne ra l chapter is published in the next e d it ion or s upple me nt to t he p h a r m a c o p o e i a a n d b e c o m e s official on the date specified for the update. It is at this point that comp a n ie s mu st comply w it h the updated requirements. It is also at this point that a request for f urther revision to a mono- g raph or chapter— or to any of the official requirements in the ph a r m a c o p o e i a — m ay b e s u b - m it ted by a compa ny or ot her stakeholder, with appropriate jus- tification for the requested revi- sion. This request would start the ph a r m acop o e ia r e v i sion c yc le over again from the beginning. While these ongoing updates pro- vide an opportunity for advocacy, more importantly they stand as the f undamental reason why a company must monitor pharma- copoeia publications to remain c o m p l i a n t w i t h t h e c u r r e n t requirements. PUBLICATION SCHEDULE FOR GLOBAL PHARMACOPOEIAS As noted above, the pharmaco - poeia rev ision process includes two stages where information is made available to stakeholders: • Draft proposals for new and revised monographs and gen- eral chapters • Updates to off icial require- ments. This information is provided by the pharmacopoeias through two types of publications and online postings: • P r o p o s a l s a r e c o m m u n i - cated through a phar maco - poeia forum, which provides stakeholders the opportunity to comment on the new or revised item • Of f ic ia l updates to genera l chapters and monographs are published in new editions and supplements to the pharmaco- poeia. All stakeholders are expected to implement the updated official requirements in the timef rame specified by the pharmacopoeia. Pr o p o s e d u p d a t e s i n p h a r m a c o - poeia forums. The forum publica- tions for global pharmacopoeias, typically available on-line and in English only, contain proposals for new and revised monographs and general chapters that are pro- vided for public review and com- ment. The forum publications for Ph. Eur., BP, and USP occur at a set frequency: four times per year for Ph. Eur. and BP and six times per year for USP ( Table I). Having visi- bility to the publication schedule is beneficial to industry for plan- ning the workload and resources Regulatory Sourcebook Pharmacopoeia Compliance Series Suggestions for new or revised monographs or general chapters may come from industry, academia, healthcare practitioners, and trade organizations.