Quality Assurance

We meet the highest international quality standards. Our quality assurance system is configured to allow continuous improvement of all departments. Our manufacturing site is regularly inspected by local health authorities and audited by customers.

Quality assurance, more than an internal department of Baccinex is a global concept implemented to reach different objectives:

  • To guarantee the compliance of our activities with regulatory requirements (GMP…)
  • To implement continuous improvement tools (corrective and preventive actions management, internal audits, risk analysis…)

Following the completion of GMP manufacturing, the decision on conformity of the batches is under the responsibility of the Qualified Person. A batch destined for a clinical trial in Switzerland can be released by the Qualified Person.