Pharmaceutical Technology - December 2019

Pharmaceutical Technology - Regulatory Sourcebook

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Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 25 company's comments from English to Chinese so a response can be provided back to the pharmacopoeial authority. For the State Pharmacopoeia of the Russian Federation (SP RF or Russian Pharmacopoeia), proposed updates are not available on a regular schedule, and when they appear, they are in Russian only, with a comparatively short time- frame to submit comments. The company's local contact group in Russia can help monitor and translate the items with potential impact. For the Indian Pharmacopoeia (IP), proposals for new and revised requirements are also posted on the commission's website on an ad hoc basis. Even though they are published in English, the irregular publication schedule for these items again makes it helpful to have a connection with the local contact group in India to assist in monitoring the website. The commenting period allowed for IP proposals also seems to be irregular and often quite short compared to the global pharmacopoeias, which makes it difficult to respond to the proposals. For many of the other national pharmacopoeias, there may be even less transparency in their public notifica- tion and commenting processes. For national pharmacopoeias, the governing commis- sion's workplan typically coincides with the publication cycle. The publication schedules for official updates (15) also reveal differences between the national pharmacopoe- ias (Table II), with translation from the local language being another complicating factor for compliance. A new edition of ChP containing official updates is published every five years in the Chinese language. The ChP commission pro- vides an English translation, but for the 2015 edition, there was a significant delay in the availability of the English ver- sion, 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 helpful in the implementation activities for industry. A new edition of the Russian Pharmacopoeia is also tar- geted every five years, but the actual publication has not strictly adhered to this intended schedule. These official up- dates to the SP RF are provided on the commission website in Russian only; an English translation is not available. The challenges with publication schedules and translations again make it critical to the success of a company's compendial vigilance program to have a strong connection with their local contact group to provide access to speedy translations of proposed and official items for assessment. The urgency for receiving the translation can be reduced as some phar- macopoeias (e.g., SP RF) allow a delayed implementation timing due to the lack of the information in English. How- ever, this is not the case with all national pharmacopoeias (e.g., ChP) where a very short time may be provided for com- pliance with the updated requirements following publica- tion in the local language. In the case where implementa- tion follows a short timeline, connection with the company's local regulatory group (or other identified function) to pro- vide the translation is critical to ensure on-time compliance. Additional information about the pharmacopoeias in India, Korea, and Brazil is provided in Table II. Conclusion The revision processes used by the pharmacopoeias, and their associated schedules for publication of proposed and official updates reveal some similarities, but also many differences between global and national pharmacopoeias. Pharmacopoeial revision activities are inextricably bound to the surveillance activities carried out by the bio/pharmaceu- tical industry. The next article in this series will take a closer look at the industry processes to monitor the significant volume of changes published in the pharmacopoeias and to remain compliant with the current requirements. Acknowledgment The authors gratefully acknowledge the contribution of Susan J. Schniepp for her technical review and helpful sug- gestions during the preparation of this series of articles. References 1. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compli- ance Is Necessary," Pharmaceutical Technology Regulatory Sourcebook eBook, 28–34 (September 2019). 2. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compli- ance Is Difficult," Pharmaceutical Technology Regulatory Sourcebook eBook, 36–42 (September 2019). 3. J. M. Wiggins and J. A. Albanese, "A Brief History of Pharma- copoeias: A Global Perspective," www.pharmtech.com (Septem- ber 2019). 4. J.M. Wiggins and J.A. Albanese, "Global Pharmacopoeia Stan- dards: Why Harmonization is Needed," Pharmaceutical Tech- nology Regulatory Sourcebook eBook, 43–47 (September 2019). 5. J. M. Wiggins and J. A. Albanese, "Harmonization Efforts by Pharmacopoeias and Regulatory Agencies," www.pharmtech. com (September 2019). 6. N. A. Schwarzwalder and R. H. Bishara, American Pharmaceu- tical Review 7 (4), 53-57 (July-Aug 2004). 7. EDQM, "Guide for the Work of the European Pharmacopoeia," EDQM.eu. 8. USP, The USP Monograph and Reference Standard Develop- ment Process, USP.org. 9. USP, Review Work Plans, USP.org. 10. USP, FAQs for USP-Transitioning from the Print/Flash Drive Format to the USP–NF Online Format, USPNF.com. 11. USP, USP–NF Accelerated Revision Process, USP.org. 12. USP, USP Guideline on Use of Accelerated Processes for Revi- sions to the USP-NF and FCC, USPNF.com. 13. USP, Pending Monographs, USPNF.com. 14. WHO, International Meetings of World Pharmacopoeias, WHO.int. 15. WHO, "Review of World Pharmacopoeias," World Health Orga- nization (WHO) Working Document QAS/12.512/Rev.1 (March 2013). 16. WHO, "Good Pharmacopoeial Practices", WHO Expert Com- mittee on Specifications for Pharmaceutical Preparations Fifti- eth Report, Technical Report Series No. 996, Annex 1, 67–85 (2016). PT

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