Commitment and management
Cebiphar’s strong and permanent commitment to quality policy guarantees the performance of its services in accordance with GMP standards, GMP, GLP and GCP quality standards.
The management of the Quality System is ensured by the Quality Assurance department whose main missions are:
- To monitor the Annual Quality Plan validated by the company’s management
- To monitor and manage the Standard Operational Procedures in force
- To program, conduct and monitor self-inspections, internal audits, study audits and subcontractors audits
- To prepare and follow-up the audits carried out by our clients
- To prepare and follow-up inspections carried out by the Authorities
The Quality Assurance department carries out the inspections of study protocols and plans as well as experimental phases, raw data and studies reports, in accordance with the specifications defined with the clients. The Quality Assurance Director validates the study by signing a Declaration of Conformity attached to the study report.
In addition, the quality optimisation programs are conducted yearly aimed to satisfy continuously the needs of ourmost demanding customers in compliance with the standards.
Certifications and compliance
Cebiphar conducts its studies in accordance with the reference quality standards in force in the countries of our clients:
GMP - Good Manufacturing Practice:
- Applicable GMP in France
- Applicable GMP in the European Union [Eudralex Volume IV]
- US cGMP (CFR21 part 210 & 211)
Our certifications as a human and veterinary pharmaceutical site:
- Pharmaceutical site certified by the ANSM since 2001. Last inspection in September 2015.
- Manufacturing site certified for the quality control of human drugs
- Manufacturing site certified for the quality control of investigational human drugs
- Manufacturing site certified for the quality control of imported drugs
- Pharmaceutical site certified by the ANSES since 2005. Last inspection in January 2015.
- Manufacturing site certified for the quality control of veterinary drugs
- Manufacturing site certified for the quality control of veterinary drugs for clinical trials
- Our certificates of GMP compliance in force issued by the ANSM and ANSES, as well as authorisation to operate as pharmaceutical establishment are available on the site: http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do (enter: *CEBIPHAR)
- Cebiphar has been successfully inspected by FDA (last inspection in September 2017)
GLP - Good Laboratory Practice:
Decree of January 28, 2005 relating to GLP for the veterinary medicinal products. Series of OECD on good laboratory practice.
- Certificate of compliance to GLP (ANSES) since 2000. Last inspection in January 2015.
GCP - Good Clinical Practice
VICH GL9: Good Clinical Practice for the veterinary medicinal products.