The CEP – Certificate of Suitability to the European Pharmacopoeia
The CEP (Certificate of Suitability to the Monographs of the European Pharmacopoeia) is a document issued by the EDQM (European Directorate for the Quality of Medicines).
It certifies that an active substance or an excipient complies with the monograph of the European Pharmacopoeia, including, where applicable, requirements related to TSE/BSE risks.
The CEP confirms that the quality of the substance can be adequately controlled through the corresponding monograph, with additional tests if necessary.
A DMF (Drug Master File), or ASMF in Europe (Active Substance Master File), is a confidential dossier submitted to regulatory authorities. It describes:
Its purpose is to demonstrate the quality and purity of the API in accordance with regulatory standards (FDA, EMA).
Compliance with GDP (Good Distribution Practices – BPD/GDP in French) is mandatory for laboratories and logistics operators.
GDP ensures:
throughout the entire supply chain, from manufacturing to final delivery.
Good Manufacturing Practices constitute a set of regulatory requirements aimed at ensuring the reproducibility of manufacturing processes by imposing standards and guidelines designed to establish a quality system that guarantees:
These practices are essential to ensure the protection of patient safety.
FRILAB aims to select partners who use raw materials certified through a DMF or CEP, and prioritizes working with manufacturing sites compliant with European GMP / BPF standards.
All manufactured medicines are stored with three key partners located in France.
All of them are GDPcertified and hold full pharmaceutical authorization.
For example, they provide:
We guarantee the shipment of our products worldwide, by sea or air, in full compliance with applicable regulations.
This includes the implementation of temperaturecontrolled transport, whether directed logistics or refrigerated (“cold chain”) shipments, monitored using temperature probes directly integrated into the goods.
Thanks to this, FRILAB is able to comply with all Incoterms required by our clients.
In every country where FRILAB Laboratories are represented, we ensure our products remain continuously available by monitoring all supply flows and guaranteeing a safety stock in each territory.
Our objective is clear: ensure continuous patient access to our products.
Certifications are issued by Swissmedic and can be consulted via the SwissGMDP database.