BioPharm International - March2020

BioPharm International - Regulatory

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www.biopharminternational.com March 2020 BioPharm International eBook 35 Regulatory Sourcebook Pharmacopoeia Compliance Series p r e v i o u s l y r e c e i v e d a p p r o v a l for their method in Europe. In essence, the currently approved met ho d i s now con side r e d a n alternative method to that in the Ph. Eur. monograph. Compliance is complicated when there are differences between compendial requirements and approved drug product registrations. For the drug substance, there is another way to ensure European r e g u l a t o r y a g r e e m e nt t o u s e methods other than those listed i n t he cor resp ond i ng Ph. Eu r. monog raph. T he procedure for "Cer t if icat ion of Su itabilit y to the Monographs of the European Pharmacopoeia" (CEP), described on the European Directorate for t he Q u a l it y of Me d ic i nes a nd HealthCare (EDQM) website (12), provides for a centralized assess- ment of applications describing the manufacture and quality con- trol of drug substances to facil- it ate a nd s i mpl i f y e xc h a n ge s between regulators and industry to ensure compliance w ith the Ph. Eur. and therefore w ith the requirements of the relevant EU legislation. The procedure com- plements and bridges the Ph. Eur. monograph and the submission of a marketing authorization dos- sier for a dr ug product. Also as noted on the EDQM website, CEPs are recognized by the signatory parties of the Ph. Eur. Convention and are also recognized by many other countries around the world, including Canada, Australia, New Zealand, Tunisia, and Morocco. CONCLUSION C ompl i a nc e w it h c omp e nd i a l standards is a legal and reg ula- tory requirement in those coun- tr ies and reg ions in which the pharmacopoeia is applicable and i s e ss e nt ia l to e n s u r e cont i n- ued availability of medicines to patients. However, compliance is complicated when there are dif- fe r e nc e s b e t we e n c omp e nd i a l requirements and approved drug product registrations. Challenges may arise in the elaboration of monog raphs by the phar maco - poeia, when differences emerge in the tests, methods, and accep- t a n c e c r it e r i a — r a n g i n g f r o m m i nor to sig n i f ica nt— bet ween t he monog raph s a nd reg i st ra- t ion s . T he s e d i f fe r e nc e s mu st be addressed to ensure ongoing compliance. Options include the addition of more quality testing or updates to product registrations to bridge any gaps. For met ho d d i f ferences, t he choices are limited, as expressed in the "MARK" principle: Merge, Add, Replace, or Keep. To achieve compliance decisions that meet both regulatory and compendial requirements, dialogue is needed bet ween impacted stakeholders in a company, including quality, reg u lator y, compend ia l a f fa irs, a nd ma ny ot hers. A lig ning on an implementation strateg y and m a i n t a i n i n g c o m m u n i c a t i o n throughout the execution of the plan are essential to achieve the best compliance outcome for the company. ACKNOWLEDGMENT The authors gratefully acknowl- edge the contribution of Susan J. Schniepp for her technical review and helpful suggestions during the preparation of this series of articles. REFERENCES 1. J.M. Wiggins and J.A. Albanese, "Monograph Development: Why and When to Participate," BioPharm International Regulatory Sourcebook eBook, 12-24 (March 2020). 2. J.M. Wiggins and J.A. Albanese, "Monograph Development: How to Participate; How to Harmonize," www. BioPharmInternational.com (March 2020). 3. M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Necessary," BioPharm International Regulatory Sourcebook eBook, 18-25 (September 2019). 4. J.M. Wiggins and J.A. Albanese, "Why Pharmacopoeia Compliance Is Difficult," BioPharm International Regulatory Sourcebook eBook (September 2019). 5. WHO, Good Pharmacopoeial Practices, WHO Expert Committee on Specifications for Pharmaceutical Preparations Fiftieth Report, Technical Report Series No. 996, Annex 1, pp. 67–85 (2016). 6. J. M. Wiggins, "Adventures in Compliance: Converging on Global Regulatory and Compendial Standards for Drug Substances and Products," Presentation at the 1st PDA Europe Pharmacopoeia Conference: Convergence, Harmonization and the Future Direction of Pharmacopoeias, Vienna, Austria (May 29–30, 2018). 7. ICH Q3A(R2) Impurities in New Drug Substances (ICH, Oct. 25, 2006). 8. ICH Q3B(R2) Impurities in New Drug Products (ICH, June 2, 2006). 9. M. Wiggins and J.A. Albanese, "Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions," BioPharm International Regulatory Sourcebook eBook, 26–39 (December 2019). 10. J. M. Wiggins and J. A. Albanese, "A Brief History of Pharmacopoeias: A Global Perspective," www. BioPharmInternational.com (September 2019). 11. EDQM, General Notices, Section 1.1 General Statements—Alternative Methods, Ph. Eur. 10th Edition (Jan. 1, 2020). 12. EDQM, "Certification of Suitability— About the Procedure—Mission & Organisation," EDQM.eu. BP

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