Organo Síntesis has facilities that meet the criteria of Current Good Manufacturing Practices (CGMP) for the manufacture of Active Pharmaceutical Ingredients (API’s) that require controlled areas. The cGMP plant has qualified equipment and areas, validated processes, calibrated instruments to carry out chemical reactions and unit operations in controlled environments.

All the operations in production, quality control, quality assurance, maintenance, warehouses and distribution, validation, training, etc., are carry out according with the International Conference of Harmonization ICH Q7 and FDA guidelines.

The program of internal audits, customer audits and National and International regulatory agencies inspections, are part of the program of continuous improvement to maintain full compliance with the regulations on the matter.