Issue link: https://www.e-digitaleditions.com/i/1193175
18 BioPharm International eBook December 2019 www.biopharminternational.com needed for the review process. The expectation is the same for each of the pharmacopoeias to their stakeholders: to review those pro- posals with potential impact and prov ide a ny com me nt s, a long with scientific rationale and sup- p or t i ng d at a r ega rd i ng i s s ue s and concerns with the proposal. Comments are typically expected within 90 days from the date the forum is published. Official updates in pharmacopoeia n e w e d i t i o n s /s u p p l e m e n t s . N e w editions and supplements to the pharmacopoeias are published to provide updated official require- ments for monographs, general chapters, and other content. These updates become official on a set date, typically six months from the date of publication, although t h is t i mel i ne ca n be d i f ferent for national pharmacopoeias. A company needs to be compliant w ith the new and rev ised gen- eral chapters and monographs by the specified official date. While it is generally allowed that the up d ate d re qu i re me nt s may b e i mplemented ea rly, it must be u nderstood t hat implement ing the requirements late does not meet the regulatory expectation of compliance with "current" phar- macopoeial requirements. The publication schedules and for mat ( hard copy and/or elec- tronic) for new editions and sup- ple me nt s a re u n ique for eac h pharmacopoeia ( Table II). The Ph. Eur., published simultaneously in both English and French as offi- cial languages, is on a three-year cycle; a new edition is published every three years with two sup- plements prov ided later in the first year, followed by three sup- plements published in each of the second and third year of the cycle (for a total of one new edi- tion and eight supplements during the three-year cycle). The Ph. Eur. is available in both pr int/hard copy and on-line formats. In the pr int version, t he supplements are non-cumulative, whereas the supplements are integrated in the electronic version, making it com- pletely cumulative. A new ed it ion of BP is pub - lished yearly in English, available in print and on-line formats. The BP does not publish supplements during the year for content that is specific to the BP but does update the on-line publication (not the hard copy version) to reflect the updates made to the Ph. Eur., as these updates are incor porated into the BP content. For USP, a new edition is pro- v ide d ye a rly i n E ng l i sh, w it h a Spanish edition available for Spanish-speak ing phar maceuti- cal scientists and professionals. The USP publishes updates to offi- cial requirements in two supple- ments to the new edition every yea r. T he USP43 – N F 38, wh ic h was scheduled for publication in November 2019, will be the last edition available in pr int/hard copy or on a USB f lash d r ive. Future supplements and editions will not be printed. Starting with the first supplement to USP43 – NF38, which will be published in February 2020, only the on-line format will be available, and it will contain all current USP–NF content (10). O t h e r t y p e s o f p h a r m a c o p o e i a updates. The pharmacopoeial pro- cesses allow for other approaches and timelines for the publication of proposed and official changes. T hese a llowa nces ca n be espe- cially important for revisions that need to be put in place quickly, for example, to address safety con- cerns related to the requirements cont a i ne d i n a ge ne r a l c h ap - ter or monog raph. T he "Guide for t he Work of t he Eu ropean Pharmacopoeia" provides for the publication of rapid revisions, as well as corrections of errors in Ph. Eur. text (7). The Ph. Eur. may also publish minor rev isions, which are justified and necessar y, but not considered controversial and do not, therefore, require prior publication in their for um as a Regulatory Sourcebook Pharmacopoeia Compliance Series Pharmacopoeia Forum publication Media type Frequency (Months) European Pharmacopoeia (Ph. Eur.) Pharmeuropa Online 4 per year (January, April, July, October) British Pharmacopoeia (BP) British Pharmacopoeia Forum Online 4 per year (January, April, July, October) United States Pharmacopeia (USP) Pharmacopeial Forum Online 6 per year (January, March, May, July, September, November) Japanese Pharmacopoeia (JP) Japanese Pharmacopoeia Forum Hard copy + 4 per year (March, June, September, December) * Other pharmacopoeias do not have a regular/consistent schedule for publication of proposed changes. + JP Forum is published in Japanese and English. Some of the proposals are also published online in English. Table I. Publication schedule for pharmacopoeia forum (proposals).*