Date Log
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Edqm Review Process for CEP
Corresponding Author(s) : K. Serena
International Journal of Allied Medical Sciences and Clinical Research,
Vol. 12 No. 4 (2024): 2024 Volume -12 - Issue 4
Abstract
In addition to the possibility of Transmissible Spongiform Encephalopathy and an examination designed for manufacturing site Certification Suitability for Monograph of European has also been introduced by the European Directorate for Healthcare and Quality Medicines with respect to the regulation of the chemical purity of Pharmaceutical constituents. The most preliminary new applicant has the right to register in Europe for medication substances for authorization of certificate of suitability of active constituents list. Certificate of Suitability of active constituents can monitor any potential impurities from the production method for the product material. This is not compulsory but serves as an essential document by decreasing the time of accumulation and authorization. Transparency of the Certificate process and the monograph makes the Pharmacopoeia of Europe extremely relevant for the registration of medications in Eurpe. In 2018, certain types of nitrosamines (N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA)) were detected in a number of active substances used in the treatment of hypertension and in related medicines.
Keywords
Download Citation
Endnote/Zotero/Mendeley (RIS)BibTeX
- European Medicines Agency, Guideline on Summary of Requirements for Active substances in the quality Part of the dossier, February 2005, 1-5 from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002813.pdf[last accessed on 6,Feb, 2017]
- Anthony C. Cartwright, Brian R. Matthews, editors, Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science, A John Wiley & Sons, Inc., Publication, 2013, Pg no: 817 fromhttps://books.google.co.in/books?id=exiu0v_pD8C&pg=PA822&dq=certificate+of+suitability+to+the+monograph+of+european+pharmaceopoeia&hl=en&sa=X&ved=0ahUKEwi8jeLvubDZA hVBNY8KHVQLBisQ6AEIOjAD#v=onepage&q=certificate%20of%20 suitability%20to%20the%20monograph%20of%20european%20 pharmaceopoeia&f=false[last accessed on 17, Feb, 2018]
- Bouin AS, Wierer M. Quality standards of the European Pharmacopoeia. Journal of ethnopharmacology. 2014 (December) 2; 158:454-7). [last accessed on 6,Feb,2018]
- Artiges A. Certification of suitability of monographs of the European Pharmacopoeia. In Annales pharmaceutiques francaises 2002 Sep (Vol. 60, No. 5, pp. 333-340). [last accessed on 6,Feb,2018]
- Council of Europe Public Health Committee, Certification of suitability to the monographs of the European Pharmacopoeia (revised version),February 2007 from https://www.edqm.eu/medias/fichiers/ cep_procedure_revised_version.pdf[last accessed on 20, Sep, 2017]
- Background & Legal Framework from https://www.edqm.eu/en/ certification-background-77.html[last accessed on 20, Dec, 2017]
- DivyaVohora, Gursharan Singh, editors, Pharmaceutical Medicine and Translational Clinical Research, academic Press, 2018from https:// books.google.co.in/books?id=ukqZDgAAQBAJ&pg=PA187&dq=Article+8(3)+Full+application&hl=en&sa=X&ved=0ahUKEwi87Yr1y8DZAhUEPo8KHTtsCvQQ6AEIKDAA#v=onepage&q=Article%208(3)%20 Full%20application&f=false[ last accessed on 28, Dec, 2017]
- Certification of Substances Division, Guidance for electronic and paper submissions for certificates of suitability (CEP) applications, June 2013 from https://www.edqm.eu/sites/default/files/guidance_for_ esubmissions_for_cep_applications-january2018.pdf[ last accessed on 28, Dec, 2017]
- Certificate of Suitability: New Applications fromhttps://www.edqm.eu/ en/certification-new-applications-29.html[last accessed on 20, Sep, 2017]
- Adrian Kilcoyne, Daniel O’Connor, Phil Ambery, editors. Pharmaceutical Medicine, Oxford Specialist Handbooks edited by Oxford University Press, First edition: 2013 Chapter 2.5, p. 34-35 Fromhttps://books. google.co.in/books?id=8MDXGLEr97YC&pg=PA35&dq=European+Directorate+for+the+Quality+of+Medicines+%26+HealthCare&hl=en&sa=X&ved=0ahUKEwiNw_1jq_ZAhUL5o8KHXTQAqkQ6AEIWTAJ#v=onepage&q=European%20Directorate%20for%20the%20Quality%20of%20Medicines%20%26%20HealthCare&f=false[last accessed on 15, Feb, 2018]
- Stefanie Schmahl, Marten Breuer, editors, The Council of Europe: Its Law and Policies from https://books.google.co.in/ books?id=thKDgAAQBAJ&pg=PA394&dq=European+Directorate+for+the+Quality+of+Medicines+%26+HealthCare&hl=en&sa=X&ved=0ahUKEwiSn3UmLDZAhXCr48KHQLkDF04ChDoAQgxMAI#v=onepage&q=European%20Directorate%20 for%20the%20Quality%20of%20Medicines%20%26%20 HealthCare&f=false[last accessed on 17, Feb, 2018]
- Hartwig Müller, editor, Medical Gases: Production, Applications, and Safety, First Edition: 2015, Wiley-VCH Verlag GmbH & Co. KGaA, chapter 4, p. 91-92 From https://books.google.co.in/books?id=DwElC%26%20HealthCare&f=false[last accessed on 16, Feb, 2018]
- History of the EDQM from 1964 to 1997 from https://www.edqm.eu/en/ History-1964-1997-1562.html[last accessed on 10,Feb, 2017]
- History of the EDQM from 1997 to 2009 from https://www.edqm.eu/en/ History-1997-2009-1561.html[last accessed on 10,Feb, 2017]
- History of the EDQM from 2010 to 2016 form https://www.edqm.eu/ EDQM-history-93.html[last accessed on 10,Feb, 2017]
- Certificate of suitability Mission & Organisation, from https://www. edqm.eu/en/certification-mission-928.html[last accessed on 25,Oct, 2017]
- Annual report 2016, European Directorate for the Quality of Medicines & HealthCare (EDQM) from https://www.edqm.eu/sites/default/files/ annual_report_edqm_2016.pdf[last accessed on 12, Sep, 2017]
- Certification of Substances Division, Terms of Reference from https://www.edqm.eu/medias/fichiers/ cep_terms_of_reference_for_certification_of_suitability_paphcep_01_1_10r.pdf [last accessed on 25, Dec, 2017]
- Certification of Substances Division , Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographsfrom https://www.edqm.eu/medias/ fichiers/guideline_on_requirements_for_revisionrenewal_of_certificates_of_suitability_to_the_european_pharmac1.pdf[ last accessed on 25,Oct, 2017]
- Certificate of suitability, Revisions & Renewals from https://www. edqm.eu/en/certification-revisions-renewals-663.html [last accessed on 5,Feb, 2017]
References
European Medicines Agency, Guideline on Summary of Requirements for Active substances in the quality Part of the dossier, February 2005, 1-5 from http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002813.pdf[last accessed on 6,Feb, 2017]
Anthony C. Cartwright, Brian R. Matthews, editors, Integrated Pharmaceutics: Applied Preformulation, Product Design, and Regulatory Science, A John Wiley & Sons, Inc., Publication, 2013, Pg no: 817 fromhttps://books.google.co.in/books?id=exiu0v_pD8C&pg=PA822&dq=certificate+of+suitability+to+the+monograph+of+european+pharmaceopoeia&hl=en&sa=X&ved=0ahUKEwi8jeLvubDZA hVBNY8KHVQLBisQ6AEIOjAD#v=onepage&q=certificate%20of%20 suitability%20to%20the%20monograph%20of%20european%20 pharmaceopoeia&f=false[last accessed on 17, Feb, 2018]
Bouin AS, Wierer M. Quality standards of the European Pharmacopoeia. Journal of ethnopharmacology. 2014 (December) 2; 158:454-7). [last accessed on 6,Feb,2018]
Artiges A. Certification of suitability of monographs of the European Pharmacopoeia. In Annales pharmaceutiques francaises 2002 Sep (Vol. 60, No. 5, pp. 333-340). [last accessed on 6,Feb,2018]
Council of Europe Public Health Committee, Certification of suitability to the monographs of the European Pharmacopoeia (revised version),February 2007 from https://www.edqm.eu/medias/fichiers/ cep_procedure_revised_version.pdf[last accessed on 20, Sep, 2017]
Background & Legal Framework from https://www.edqm.eu/en/ certification-background-77.html[last accessed on 20, Dec, 2017]
DivyaVohora, Gursharan Singh, editors, Pharmaceutical Medicine and Translational Clinical Research, academic Press, 2018from https:// books.google.co.in/books?id=ukqZDgAAQBAJ&pg=PA187&dq=Article+8(3)+Full+application&hl=en&sa=X&ved=0ahUKEwi87Yr1y8DZAhUEPo8KHTtsCvQQ6AEIKDAA#v=onepage&q=Article%208(3)%20 Full%20application&f=false[ last accessed on 28, Dec, 2017]
Certification of Substances Division, Guidance for electronic and paper submissions for certificates of suitability (CEP) applications, June 2013 from https://www.edqm.eu/sites/default/files/guidance_for_ esubmissions_for_cep_applications-january2018.pdf[ last accessed on 28, Dec, 2017]
Certificate of Suitability: New Applications fromhttps://www.edqm.eu/ en/certification-new-applications-29.html[last accessed on 20, Sep, 2017]
Adrian Kilcoyne, Daniel O’Connor, Phil Ambery, editors. Pharmaceutical Medicine, Oxford Specialist Handbooks edited by Oxford University Press, First edition: 2013 Chapter 2.5, p. 34-35 Fromhttps://books. google.co.in/books?id=8MDXGLEr97YC&pg=PA35&dq=European+Directorate+for+the+Quality+of+Medicines+%26+HealthCare&hl=en&sa=X&ved=0ahUKEwiNw_1jq_ZAhUL5o8KHXTQAqkQ6AEIWTAJ#v=onepage&q=European%20Directorate%20for%20the%20Quality%20of%20Medicines%20%26%20HealthCare&f=false[last accessed on 15, Feb, 2018]
Stefanie Schmahl, Marten Breuer, editors, The Council of Europe: Its Law and Policies from https://books.google.co.in/ books?id=thKDgAAQBAJ&pg=PA394&dq=European+Directorate+for+the+Quality+of+Medicines+%26+HealthCare&hl=en&sa=X&ved=0ahUKEwiSn3UmLDZAhXCr48KHQLkDF04ChDoAQgxMAI#v=onepage&q=European%20Directorate%20 for%20the%20Quality%20of%20Medicines%20%26%20 HealthCare&f=false[last accessed on 17, Feb, 2018]
Hartwig Müller, editor, Medical Gases: Production, Applications, and Safety, First Edition: 2015, Wiley-VCH Verlag GmbH & Co. KGaA, chapter 4, p. 91-92 From https://books.google.co.in/books?id=DwElC%26%20HealthCare&f=false[last accessed on 16, Feb, 2018]
History of the EDQM from 1964 to 1997 from https://www.edqm.eu/en/ History-1964-1997-1562.html[last accessed on 10,Feb, 2017]
History of the EDQM from 1997 to 2009 from https://www.edqm.eu/en/ History-1997-2009-1561.html[last accessed on 10,Feb, 2017]
History of the EDQM from 2010 to 2016 form https://www.edqm.eu/ EDQM-history-93.html[last accessed on 10,Feb, 2017]
Certificate of suitability Mission & Organisation, from https://www. edqm.eu/en/certification-mission-928.html[last accessed on 25,Oct, 2017]
Annual report 2016, European Directorate for the Quality of Medicines & HealthCare (EDQM) from https://www.edqm.eu/sites/default/files/ annual_report_edqm_2016.pdf[last accessed on 12, Sep, 2017]
Certification of Substances Division, Terms of Reference from https://www.edqm.eu/medias/fichiers/ cep_terms_of_reference_for_certification_of_suitability_paphcep_01_1_10r.pdf [last accessed on 25, Dec, 2017]
Certification of Substances Division , Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the European Pharmacopoeia Monographsfrom https://www.edqm.eu/medias/ fichiers/guideline_on_requirements_for_revisionrenewal_of_certificates_of_suitability_to_the_european_pharmac1.pdf[ last accessed on 25,Oct, 2017]
Certificate of suitability, Revisions & Renewals from https://www. edqm.eu/en/certification-revisions-renewals-663.html [last accessed on 5,Feb, 2017]