QUALITY POLICY

Through our quality system, provide to our customers with products that are safe and effective, which are produced, distributed and endorsed, according to the highest standards of quality.

Organo Sintesis has a Quality System that complies with stringent quality standards based on the Current Good Manufacturing Practices.

Organo Sintesis has a Quality Unit independent of Production Department that meets the responsibilities of Quality Assurance and Quality Control, ensuring the compliance of the quality policy.

All employees of the company are responsible for the quality of the products manufactured, in addition, they have the individual commitment of ensuring that their work contribute effectively in the compliance of the necessities of our customers.

The Quality Committee is composed up by members from different disciplines: Quality Control, Quality Assurance, Researchand Development, Production, Engineering and Maintenance, whose main function is analyze and solve problems regarding to deviations to the Quality System.

QUALITY CONTROL

Organo Sintesis has highly qualified staff working in quality activities whose main responsibility is guarantee the releasing products with World Class quality level.

Quality Control staff apply the best analytical available technologies and Good Laboratory Practices.

To ensure our product meet with highest quality standards, Organo Sintesis has a well-equipped quality control laboratory. The main instruments are the following: UV-visible spectrophotometers, FT-Infrared spectrophotometers, Gas chromatographs (GC), High Performance Liquid Chromatographs (HPLC), GC coupled with mass detector (GC-MS), GC coupled with head-space sampler (GC-HS), Particle size laser analyzers, pH meters, furnaces, ovens, Karl-Fisher titrators, etc.

The main activities and responsibilities of the Quality Control Department are the following:

  • Raw materials, intermediate and final product analysis
  • In process control analysis
  • Cleaning / change of equipment analysis
  • Stability studies
  • Support to process development
  • Development and validation of analytical methods
  • Transfer of methods
  • Release of raw materials and intermediates

After several quality audits from multinational customers, the company has been certified as reliable supplier, demonstrating the effectiveness of our Quality System.

QUALITY ASSURANCE

The Quality Assurance System in our company provide satisfactory evidence that the production processes ensure that our products are consistently manufactured complying with the most demanding requirements of our customers.

The system also seeks to ensure that each part of the business improves its performance becoming a more productive and competitive company through a proces of continuous improvement that results form the outcomes of internal and external audits.

The Quality Assurance Department has developed a Quality System Manual, in which the requirements of the Current Good Manufacturing Practices (cGMP’s) are set in accordance with international guidelines such as ICH Q7 and the USFDA.

As a result of all these efforts, our company has been repeatedly certified as reliable supplier by World Class companies, which have also undergone our facilities to rigorous quality audits.