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LABORATORIOS SAVAL

Quality Standards and Good Manufacturing Practices

Laboratortios SAVAL is committed to Continuous Improvement activities, Total Quality programs and World Class Manufacturing Sandards; along with a comprehensive plan for environmental protection.

Obtaining a quality SAVAL medicine product is the result of rigorous planning and the combined efforts of all members of the Company, which rules their production processes based on operational designs recommended by the World Health Organization, through the "Current Good Manufacturing Practices" (cGMP) standards, which goal is to achieve excellence in quality standards for pharmaceutical production. 

Saval´s production facilities have been designed according to the International Society of Pharmaceutical Engineering (ISPE) guidelines, recommended by the Food and Drug Administration (FDA), which are applied in U.S.A. and other developed countries; according as well with the guidelines of the World Health Organization (WHO) and the International Organization for Standardization (ISO) 14644.

The use of computer programs based on Manufacturing Resource Planning (SAP / R3) guarantees and optimize the usage of resources in order to maintain the highest standards of accuracy and quality.

Laboratorios Saval has a quality system  based on all the aspects described in the WHO´s Good Manufacturing Practices which ensures the quality of all of Laboratorios Saval products, from the purchase and reception of supplies, which is supported from the supplier´s qualification program, up to the obtaining of the finished product, which is the result of a series of controlled steps.  Every stage is supported by training, maintenance, calibration, cleaning and sanitization, validation and qualification programs and document management among others.

In this sense, Laboratorios Saval has a quality policy that has been signed by the Company´s senior management and board that declares their overall intentions and willingness in relation to global quality standards. This policy is summarized in the following paragraph:

“Laboratorios Saval S.A. declares its commitment to continuously improve their processes in order to provide our customers medicines manufactured under the highest quality standards, in full compliance with Good Manufacturing Practices (GMP) recommended by the World Health Organization, in force in Chile”.

Quality Certifications:

Laboratorios Saval S.A. is certified by the Chilean  regulatory agency, Instituto de Salud Pública (ISP), in compliance with the Good Manufacturing Practices (GMP) standards recommended by the World Health Organization.

It also has been certified by the Colombian National Institute of Food and Drug Monitoring (INVIMA), in compliance with the Good Manufacturing Practices (GMP) Standards recommended by the World Health Organization (WHO).