procedimientos y distribucion

GMP

LIBRA owns one of the few Uruguayan pharmaceutical plants certified according to the latest GMP (Good Manufacturing Practices) in force of the World Health Organization, and of the demanding Agencia Nacional de Vigilancia Sanitaria (ANVISA) from Brazil. Produces plants approved by different health authorities, Uruguay and Latin America: National Institute for Drug and Food Surveillance (INVIMA Colombia), ANVISA Brazil and the National Drug Administration, Food and Medical Technology (ANMAT Argentina).

aprobacion de los productos para la venta

Quality Control

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.

validacion de procesos sistemas y metodologias

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.

calificacion de equipos y proveedores

Pharmacovigilance

Monitors the safety of the products through the Pharmacovigilance Program.

control sanitario del personal

Human Resources

The work is carried out by teams of highly trained personnel, committed to maintaining the company’s quality standards and objectives.

auditorias internas y externas

Quality Assurance

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

 

 

 

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