Below is an attestation of ANSM inspection to verify our compliance with Part II of EU current Good Manufacturing Practices ("cGDPs") for medicinal products for human and veterinary use. We focus specifically on chapter 17: distribution operations of actives substances.
ANSM authorization for importation and distribution of Active Pharmaceutical Ingredients ("APIs") and excipients number 2022-00778
The GDP standards fully describe the distribution process from the API manufacturing facilities to the pharmaceutical Finished Product Marketing Holder end user. This makes it part of the whole quality most important principles.
Quality Management System ("QMS")
This is the system that describes every single step of the distribution process. According to GDP, every distributor should have a QMS in place.
- Our QMS is adapted to all internal and external processes and fully documented according to cGDPs
- We employ an expert PharmD Responsible Person with clearly defined responsibilities
- Top of the class Change Control System as part of our QMS
- High level Annual Quality Management Review processes
- Our Quality Risk Management is a systematic process for the assessment, control, communication and review of any risks potentially impacting the quality of the final drug product across the supply chain
- We use highly detailed Deviation Management, Corrective Action and Preventive Action ("CAPA") processes
Personnel and equipment
An adequate number of competent personnel is involved in all stages of the wholesale distribution activities of Active Pharmaceutical Ingredients. The number of personnel and IT resources required is adjusted to the volume and scope of activities with a clear organizational structure.
All Socosur personnel involved in the distribution process are trained to GDPs according to their role and responsibilities.
Need for GDPs implementation
As the Pharmaceutical and Biotechnology industries become more global, more APIs and drug products are being manufactured in one region and then transported/imported/exported to other regions around the globe.
As a result, supply chain safety, validation and Good Storage and Distribution Practices have become much more critical and relevant in this era.
Any uncontrolled or unsafe supply chain may lead to major deviations related to product safety and API qualifications that can easily lead to drug product recalls or even endanger patients health.