Management of Investigational Medicinal Products 
Clinical Trial Logistics
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Quality Assurance

Efficient Quality Assurance System

Theradis Pharma is committed to a Quality Assurance policy that expresses their respect of the regulations in force, as well as the desire to continually improve the services provided, in order to satisfy the client who demands a service of quality.

For Theradis Pharma it is a question of the company’s global politic which concerns all of the departments in the Company and the entire staff.

For this, we rely upon a team of managers experienced in the establishment of a Quality Assurance system along with it’s continuous improvement.

Several members of the management have participated in ISO 9002 certification and all of the staff has been implicated in the Quality processes of either service companies or other companies for whom they have worked.

Equally, we are supported by the skills an external advisor, an expert in the field of Assurance Quality, in order to set up and develop our Assurance Quality system..

Ever attentive to continually evolving regulatory requirements and conscious of the professionalism of logistic services for clinical trials, we commit the entire Company to this Quality process. This begins with the management of the Investigational Medicinal Products, but equally spreads to all of our activities, concerning the material, documents, organisation of logistic solutions and in a more general manner the totality of our services.

Our professional ethic is to conform to the strictest regulatory requirements, in order to propose an increasingly performing service, with a politic of transparency with regards to our clients in order to obtain their lasting satisfaction.

Regulatory Framework and Working References
In a European and National Regulatory framework, our working references are the Good Manufacturing Practice, Good Distribution Practice and Good Clinical Practice
Structure of Documentation

The structure of the documentation required for Theradis Pharma Quality system is established according to four levels :

  • Level 1 : The  Quality Manual that defines the Company’s Quality policy
  • Level 2 : The Organisational and Operational procedures
  • Level 3 : The standard documents
  • Level 4 :  Working instructions
Quality Control
Documented quality control operations are set up at each of the key steps and are integrated into the actual processes. The results of these controls participate in the improvement of the quality. 
Satisfaction surveys
The final control of a service is carried out using a satisfaction survey.
Internal Audits

An annual internal audit programme is elaborated with, as it’s goal, the verification of the efficiency of the organisation established by Theradis Pharma in order to obtain a consistent quality of their entire service.

Quality Indicators
The quality indicators put in place allow an evaluation of the operational performance in a continuous manner and in this way manage the operational risk.
Staff Training
All staff members follow an initial and general training adapted to their post as well as a training specific to each study.

All training sessions, initial or continual, individual or collective, internal to the Company or external, are recorded.
Permanent improvement process of QA System :
  • Audit planning
  • Putting in place corrective actions
  • Planning the revision of procedures
  • Planning staff training
  • Set up of preventative actions
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