Issue link: https://www.e-digitaleditions.com/i/1193175
22 BioPharm International eBook December 2019 www.biopharminternational.com available official publication. If c i rc u m st a nce s re qu i re a more rapid publication of official text, a revision bulletin is posted on t he USP website w it h t he of f i- c ia l d ate i nd icated. E r rat a a re published to correct content in the USP that does not accurately r e f le c t t he i nte nd e d r e qu i r e - ments as approved by the experts, and may address inaccuracies in chemical formulas, mathematical equations relevant to analyses, or inaccurate descriptions of appara- tus or materials used in analytical tests. The USP also publishes com- pendial notices to inform stake- holders of the changing status of monographs and general chapters, for example, to modif y general chapter titles, appendix titles, or references to external resources that may be listed throughout the pharmacopoeia. These processes for accelerated revisions do not a lway s r e qu i r e p ubl ic at ion i n the forum and allow revisions to become official prior to the next edition or supplement. There is another process for USP pending monographs to allow development of new or rev ised monog raphs for articles awaiting approval by FDA (13). USP also publishes stim- uli articles, which present initial thinking of the experts in their development of new or rev ised general chapters or other stan- dards and provide additional time for com ments f rom sta kehold- ers. The wide array and frequent use of these other approaches to notif y stakeholders of proposed and official updates makes routine (monthly) monitoring of the USP website an important component of a company's surveillance pro- cess to remain in compliance with current requirements. REVISION PROCESS AND PUBLICATION SCHEDULE FOR JP Shifting focus from the global to the national pharmacopoeias, spe- cial consideration should be given to JP, because it does not fit as eas- ily into the global or national des- ignations. Because it is primarily required in Japan only, the JP is a national pharmacopoeia accord- ing to the authors' definitions. The revision process and regular pub- lication schedule for JP, however, more closely align with those of the global pharmacopoeias, making it simpler for a company to include JP in their surveillance activities. As with the global pharmacopoe- ias, the JP revision process includes steps that are internal to the organi- zation and steps that connect with external stakeholders, with com- munication of proposed and offi- cial updates occurring on a regular basis. Table I shows that proposed updates are published four times per year in the JP forum on an established schedule. The JP forum is published in a hard copy/print version only, although some of the proposed revisions are also posted on the JP website for review and comment. The JP forum is provided in both the Japanese and English languages within the same print copy, but the entire content is not exactly the same in each publica- tion due to delays in translation of some of the proposals. This trans- lation timing may make it difficult for a company to provide a timely response to revisions published in the JP forum. Table II reveals that official JP updates are published in a new edition every five years, with two supplements published during the five-year cycle between editions. Partial revision to official JP requirements may also be made at any time on the JP website, if necessary. The new JP editions and supple- ments are published in hard copy/ print versions, first in Japanese (the official language) and subse- quently in English. Free, on-line PDF versions of the official JP edi- tion and supplements are avail- able on the JP website, in both Japanese and English, although the English version may not be t he most c u r rent ed it ion. T he English translation may take up to 12 months for completion, but this delay is taken into account in establishing the official date, which is usually set at 18 months a f te r t he of f ic ia l p ubl ic at ion. E x p e r i e n c e h a s s h ow n , h ow - ever, that compliance for compa- nies located in Japan is expected sooner. This situation creates the potential for inconsistencies in the procedures and documenta- tion for a multi-national company rega rd i ng up d ate d J P re qu i re - ments if there are manufact ur- ing sites both inside and outside of Japan. Because of this, some companies may implement new JP requirements based on the offi- cial Japanese version, which pro- vides extra time to complete the necessary change control activi- ties. The benefits for a company to translate from the Japanese to enable implementation of updated JP requirements and the earlier Regulatory Sourcebook Pharmacopoeia Compliance Series Contin. from page 19 The revision process and regular publication schedule for JP more closely align with those of the global pharmacopoeias.