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20 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series Proposed updates in pharmacopoeia forums. The forum publi- cations for global pharmacopoeias, typically available on-line and in English only, contain proposals for new and revised monographs and general chapters that are provided for pub- lic review and comment. 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 visibility to the publication schedule is beneficial to industry for planning the workload and resources needed for the review process. The expectation is the same for each of the pharmacopoeias to their stakeholders: to review those proposals with potential impact and provide any comments, along with scientific rationale and supporting data regard- ing issues and concerns with the proposal. Comments are typically expected within 90 days from the date the forum is published. Official updates in pharmacopoeia new editions/supplements. New editions and supplements to the pharmacopoeias are published to provide updated official requirements for monographs, general chapters, and other content. These updates become official on a set date, typically six months from the date of publication, although this timeline can be different for national pharmacopoeias. A company needs to be compliant with the new and revised general chapters and monographs by the specified official date. While it is gener- ally allowed that the updated requirements may be imple- mented early, it must be understood that implementing the requirements late does not meet the regulatory expectation of compliance with "current" pharmacopoeial requirements. The publication schedules and format (hard copy and/or electronic) for new editions and supplements are unique for each pharmacopoeia (Table II). The Ph. Eur., published simul- taneously in both English and French as official languages, is on a three-year cycle; a new edition is published every three years with two supplements provided later in the first year, followed by three supplements published in each of the sec- ond and third year of the cycle (for a total of one new edition and eight supplements during the three-year cycle). The Ph. Eur. is available in both print/hard copy and on-line formats. In the print version, the supplements are non-cumulative, whereas the supplements are integrated in the electronic ver- sion, making it completely cumulative. A new edition of BP is published yearly in English, avail- able 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 ref lect the updates made to the Ph. Eur., as these updates are incorporated into the BP content. For USP, a new edition is provided yearly in English, with a Spanish edition available for Spanish-speaking pharma- ceutical scientists and professionals. The USP publishes up- dates to official requirements in two supplements to the new edition every year. The USP43–NF38, which was scheduled for publication in November 2019, will be the last edition available in print/hard copy or on a USB f lash drive. 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). Other types of pharmacopoeia updates. The pharmacopoeial processes allow for other approaches and timelines for the publication of proposed and official changes. These allow- ances can be especially important for revisions that need to be put in place quickly, for example, to address safety concerns related to the requirements contained in a general chapter or monograph. The "Guide for the Work of the 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 revisions, which are justified and necessary, but not considered controversial and do not, therefore, require prior publication in their forum as a proposal. While perhaps not controversial, these minor revisions often still have impact, and a company may find it challenging to implement the changes quickly, after they are seen for the first time as official updates. USP's "Rules and Procedures of the Council of Experts" specify processes that can be used to make official revisions to the USP–NF more quickly than through their standard process (8,11,12). These accelerated processes include the publication of interim revision announcements (IRAs), re- 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 Hardcopy + 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).*