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24 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m Pharmacopoeia Compliance Series 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 publication due to delays in translation of some of the pro- posals. This translation 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 supple- ments 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 supplements are published in hard copy/print versions, first in Japanese (the official lan- guage) and subsequently in English. Free, on-line PDF ver- sions of the official JP edition and supplements are available on the JP website, in both Japanese and English, although the English version may not be the most current edition. The English translation may take up to 12 months for com- pletion, but this delay is taken into account in establishing the official date, which is usually set at 18 months after the official publication. Experience has shown, however, that compliance for companies located in Japan is expected sooner. This situation creates the potential for inconsis- tencies in the procedures and documentation for a multi- national company regarding updated JP requirements if there are manufacturing sites both inside and outside of Japan. Because of this, some companies may implement new JP requirements based on the official Japanese ver- sion, which provides extra time to complete the necessary change control activities. The benefits for a company to translate from the Japanese to enable implementation of updated JP requirements and the earlier opportunity to respond to JP proposals make it important for the com- pendial affairs group in a company to have a strong con- nection with their local contact group in Japan, if available. Compliance with compendial requirements in Japan is also made more difficult by the publication (not on a regular schedule) of official compendia other than JP. Examples of these include Japanese Pharmaceutical Excipients; Japanese Pharmaceutical Codex; Japan's Specifications and Standards for Food Additives; Requirements for Antibiotic Products of Japan; and Minimum Requirements for Biological Products in Japan. The health authorities in Japan expect compliance with these additional compendial requirements if standards do not otherwise exist in the official JP. Revision process and publication schedule for other national pharmacopoeias Looking at the revision process and publication schedules for other national pharmacopoeias, it is apparent that there are differences from the global pharmacopoeias and from each other. These differences, in particular the irregular publication schedules and the need for translation, pose challenges for industry surveillance activities and neces- sitate partnership with a company's local contact group, if available, in these countries to help with compliance. Dif- ferences between the pharmacopoeias have been explored in the International Meetings of World Pharmacopoeias convened by the World Health Organization (14, 15), which have focused on ways to achieve international harmoniza- tion among the many pharmacopoeias. One outcome of these discussions has been the publication of Good Phar- macopoeial Practices (GPhP), which defines approaches and policies in establishing pharmacopoeial standards (16). One key consideration contained in the GPhP document is the assurance of an open and transparent process throughout the development and revision of pharmacopoeial standards. This process calls for engaging stakeholders in the process by making workplans available and providing adequate and timely public notification with allowances for commenting. While the revision processes for national pharmacopoeias typically follow similar steps as previously described, there is not always a similar level of transparency as seen with the global pharmacopoeias. National pharmacopoeias do not publish their proposed revisions for public comment at a predetermined time; it typically happens in an ad-hoc fashion. The lack of a regular schedule for notification of proposals contributes to the challenge for industry in moni- toring the national pharmacopoeias. The Chinese Pharmacopoeia (ChP) commission, for ex- ample, publishes items for comments on its website when a sufficient number of new and revised monographs and general chapters have progressed through their develop- ment process. These proposals are published in Chinese only. Comments on first draft items typically receive a 90- day commenting period, whereas items that are second or subsequent drafts typically get only 30 days for comment- ing. Many large multi-national companies find it difficult to meet the commenting deadlines for ChP since the proposals must first be translated into English to enable assessment of the potential impact. It is important, therefore, for the compendial affairs function in a company to have a strong connection to the local contact group in China, if available (e.g., regulatory affairs, quality, etc.) to perform the monitor- ing, identification, and translation of items with potential impact. If needed, the local group can also translate the The irregular publication schedules of national pharmacopoeias and the need for translation pose challenges for industry surveillance activities.