Documentation and compliance
SiTec Consulting can review your dossier and prepare expert reports to support your application for Certification of Suitability of Monographs of the European Pharmacopoeia (CEP): TSE Risk Assessment and Chemical Purity.
Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) are granted by the Certification Secretariat of the European Directorate for the Quality of Medicine (www.pheur.org). Recognised by 34 signatory states of the European Pharmacopoeia Convention and by the European Union, CEP can be used by the manufacturers of pharmaceutical products in their applications for marketing authorisation to demonstrate the compliance of the substance with the monographs of the European Pharmacopoeia and Directives 2001/83/EC and 2001/82/EC.
By means of a CEP, an API manufacturer will be able to provide proof that the quality of a substance is suitably controlled by the relevant monographs of the European Pharmacopoeia, and whether it can be used in medicinal products.
According to the official procedure, manufacturers or suppliers of substances for pharmaceutical use (API or excipient manufacturers) can apply for either or both certificates concerning:
- The evaluation of the suitability of the monograph to control chemical purity and microbiological quality of their substance, according to the corresponding specific or general monographs,
- or the evaluation of reduction of Transmissible Spongiform Encephalopathy (TSE) risk, according to the general monograph.
SiTec Consulting can provide API and excipient manufacturers with valuable assistance in preparing and reviewing their dossiers when applying for Certificates of Suitability: either for Chemical Purity or TSE risk Assessment.
We will examine your dossiers and prepare Expert Reports and Quality Overall Summaries (QOS). We are committed to accompany your application throughout the certification process, until the certificate is granted.