Its quality control laboratory is equipped to the highest regional level. It is continually updated and has specialized areas for the analysis of segregated products. It ensures meeting the latest international pharmacopeial specifications.
Exchangeability and clinical studies
LIBRA has a Program for Pharmaceutical Equivalence and Bioequivalence that certifies its products, guaranteeing both doctors and patients that the product indicated is safe and reliable.
The research is carried out by Brazilian Organizations approved by ANVISA and the Centro de Biodisponibilidad y Bioequivalencia de Medicamentos (CEBIOBE) from the University of the Republic of Uruguay.
Committed to the development of safe and effective products LIBRA invests in clinical studies working in cooperation with the Academia. This is done in a responsible way following the highest standards of ethics.
Monitors the safety of the products through the Pharmacovigilance Program.
The work is carried out by teams of highly trained personnel, committed to maintaining the company’s quality standards and objectives.
Quality Management System comprises:
- designing, revision, approval of procedures and its distribution control
- product release for sale
- validation of processes, systems and analytical methods
- equipment qualification
- stability program for all products
- suppliers qualification
- nonconformities follow-up
- recall system
- staff training
- internal and external audits
- health checks of staff