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24 BioPharm International eBook December 2019 tion, but for the 2015 edition, there was a significant delay in the avail- ability of the English version, which made it difficult for multi-national companies to comply with the updated requirements. For the ChP 2020 edition, there are indications that the English translation will be available more quickly after the Chinese version, which will be help- ful in the implementation activities for industry. A new edition of the Russian Phar macopoeia is a lso ta rgeted every five years, but the actual pub- lication has not strictly adhered to this intended schedule. These off icial updates to the Russian Pharmacopoeia are provided on the commission website in Russian only; an English translation is not available. The challenges with publication schedules and transla- tions again make it critical to the success of a company's compen- dial vigilance program to have a strong connection with their local contact group to provide access to speedy t ra nslat ions of pro - posed and official items for assess- ment. The urgency for receiving the translation can be reduced as some pharmacopoeias (e.g., Russian Phar macopoeia) allow a delayed implementation timing due to the lack of the information in English. However, this is not the case with all national pharmacopoeias (e.g., ChP) where a very short time may be provided for compliance with t he updated requ i rements fol- lowing publication in the local language. In the case where imple- mentation follows a short timeline, connection with the company's local regulatory group (or other identified f unction) to prov ide the translation is critical to ensure on-time compliance. Additional information about the pharmaco- poeias in India, Korea, and Brazil is provided in Table II. CONCLUSION The revision processes used by the pharmacopoeias, and their asso- ciated schedules for publication of proposed and official updates reveal some similarities, but also many differences between global a nd nat iona l pha r macopoeias. Pharmacopoeial revision activities are inextricably bound to the sur- veillance activities carried out by the bio/pharmaceutical industry. The next article in this series will take a closer look at the industry processes to monitor the signifi- cant volume of changes published in t he pha r macopoeias a nd to remain compliant with the cur- rent requirements. ACKNOWLEDGMENT The authors gratefully acknowl- edge the contribution of Susan J. Schniepp for her technical review and helpf ul suggestions during the preparation of this series of articles. REFERENCES 1. J. M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Necessary," BioPharm International Regulatory Sourcebook, 18–25 (September 2019). 2. J. M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Difficult," BioPharm International Regulatory Sourcebook, 26–34 (September 2019). 3. J. M. Wiggins and J. A. Albanese, "A Brief History of Pharmacopoeias: A Global Perspective," www.BioPharmInternational. com (September 2019). 4. J. M. Wiggins and J.A. Albanese, "Global Pharmacopoeia Standards: Why Harmonization is Needed," BioPharm International Regulatory Sourcebook, 36–41 (September 2019). 5. J. M. Wiggins and J. A. Albanese, "Harmonization Efforts by Pharmacopoeias and Regulatory Agencies," www.BioPharmInternational. com (September 2019). 6. N. A. Schwarzwalder and R. H. Bishara, American Pharmaceutical Review 7 (4), 53-57 (July–August 2004). 7. EDQM, "Guide for the Work of the European Pharmacopoeia," 8. USP, The USP Monograph and Reference Standard Development Process, 9. USP, Review Work Plans, 10. USP, FAQs for USP-Transitioning from the Print/Flash Drive Format to the USP–NF Online Format, 11. USP, USP–NF Accelerated Revision Process, 12. USP, USP Guideline on Use of Accelerated Processes for Revisions to the USP-NF and FCC, 13. USP, Pending Monographs, 14. WHO, International Meetings of World Pharmacopoeias, 15. WHO, "Review of World Pharmacopoeias," World Health Organization (WHO), Working Document QAS/12.512/Rev.1 (March 2013). 16. WHO, "Good Pharmacopoeial Practices", WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth Report, Technical Report Series No. 996, Annex 1, 67-85 (2016). BP The irregular publication schedules of national pharmacopoeias and the need for translation pose challenges for industry surveillance activities. Regulatory Sourcebook Pharmacopoeia Compliance Series

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