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Challenges and Prospects for Filing Certificate of Suitability in Europe
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| Author:
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ANANDH S, RAJU KAMARAJ, ABIMANYU SUGUMARAN
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| Abstract:
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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
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| Keyword:
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CEP in EUROPE, Sister file, TSE, Nitrosamine contamination, Valsartan, Ranitidine Hcl
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.02.350
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| Download:
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Request For Article
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