Regulatory & Quality Compliance

Through quality excellence in every single step of the process, we meet one of Gador’s goals providing our clients with the required distinguished service, in order to remain competitive. This is achieved through special care placed on complete and accurate documentation, dynamic response to customers and authorities with the necessary technical support that facilitates a fast track regulatory approval.

DMFs for USA, Australia and Europe are prepared and provide.

Once the documents get the corresponding approval, the authorities and customers are periodically updated.

Gador S.A. API Division has successfully undergone a number of inspections carried out by the Food and Drug Administration from the USA (FDA), the Therapeutic Good Administration from Australia (TGA), The agence Française de sécurité sanitaire des produits de santé (AFFSAPS), and the MERCOSUR health authorities. The company also hosts audits from clients from Europe, United States of America, Asia and Australia on a regular basis.

Our Quality Policy

We reach quality standards with our products, not only by meeting specifications, but also by ensuring reproducibility and consistency in each stage of the Manufacturing Process.
A quality Management System is in place in order to ensure process reproducibility through measurable criteria set at relevant functions and levels within Gador S.A. API Division. Management review at regular intervals ensures the continuing suitability, adequacy and effectiveness.
Customer satisfaction is achieved by determining and meeting customer requirements.

Personnel qualification and training are a major issue for our Company. In accordance to this premise, more than 50% of our employees are University Graduates and receive the required on going training to guarantee the best state of knowledge, skill and motivation. The aim is to ensure that their performance meets international standards.

The management hereby instructs each and all employee working in GADOR S.A. API Division, to follow and act according to the rules and principles laid down in the Quality Manual (SOP system).

Quality Unit

Gador S.A. API Division has both Quality Assurance and Quality Control functions in a defined organizational structure.
The Quality Unit is responsible for the implementation of a quality system that ensures compliance with local and international regulations, current Good Manufacturing Practices (cGMP) and Company policies. We innovate through working on organizational values.
The Quality Control Department is responsible for testing and providing data of raw, packaging materials and manufactured products.
The Company follows the specifications and test methods as per USP and EP. The Company also has additional in-house laid down specifications and test methods for raw and packing materials and manufactured products for better control of quality products.
Our laboratories are fully equipped with state of the art instrumentation and staffed with highly qualified personnel.

Main Equipment

• 3 GC
• 4 HPLC Units (DAD and UV-VIS)
• 1 UV – VIS Spectrophotometer
• 1 Fourier Transform Infra-Red
• 1 Particle Analyzer
• 1 Tapped Density Analyzer
• 2 IR Balance
• 3 Karl Fischer Titrators
• 2 Automatic Titrators
• 1 Total Organic Carbon (TOC)