Regulatory compliance is key to our clients’ satisfaction.

#RegulatoryCompliance #QualityManagementSystem #ManufacturingBestPractices

Several processes are implemented at Cevidra to ensure the compliance of pharmaceutical operations with the Public Health Code and with Good Manufacturing & Distribution Practices.

Regulatory monitoring
Change control
Control of operations

Regulatory monitoring

Our regulatory monitoring system constitutes the first pillar of our regulatory compliance. To conduct this monitoring, we have implemented a set of tools that inform us in real-time and allow us to anticipate any changes in pharmaceutical regulation.

The main tool used by CEVIDRA is membership in a pharmaceutical association that conducts this monitoring for all its members.

Cevidra backs this tool by registering all its pharmacists to personalized monitoring and the Newsletters published by the ANSM and the order of pharmacists.


Change Control

The second pillar of our compliance policy is our change control system.

This system enables us to assess the impact of regulatory change on all our organisation’s components, in particular impact on quality control paperwork, human and material resources, impact on IT systems, etc…

This assessment is conducted in an organized and collective way as to not miss any of the impacts, to respond to them fully and meet the deadline set by public authorities.

The implementation of all the actions derived from this analysis means we update our Quality Management system to new requirements.


Control of operations

This compliance’s third pillar is the control of operations performed or subcontracted by CEVIDRA. As previously mentioned, this control is based on the translation of regulatory requirements into our Quality processes and guidelines, but also on the training of employees and on the implementation of a self-inspection system


Main takeaways