欧盟CEP*原料辅料
Site information
CEP证书(The Certificate of Suitability to the Monographs of the European Pharmacopoeia 欧洲药典适用性证书)。用以证明生产厂家所申报的产品符合欧洲药典的标准要求,生产符合EGMP及ICHQ7的要求。
Highlights
**EDQM CEP Raw Materials and Reagents**
The European Directorate for the Quality of Medicines & HealthCare's (EDQM) CEP provides a way to officially recognize the suitability of active pharmaceutical ingredients (APIs) and excipients used in the manufacture of human and veterinary medicines for use in the European Pharmacopoeia (Ph. Eur.). CEPs are granted following a rigorous assessment process that evaluates the quality and safety of the API or excipient.
**Highlights:**
* **Official recognition:** CEPs provide official recognition of the suitability of APIs and excipients for use in the Ph. Eur.
* **Quality and safety:** CEPs are granted following a rigorous assessment process that evaluates the quality and safety of the API or excipient.
* **Transparency:** The CEP process is transparent, with all relevant information being published on the EDQM website.
* **Harmonization:** CEPs contribute to the harmonization of the European药品市场, ensuring that APIs and excipients meet the same high standards of quality and safety across the region.