Producing Active Pharmaceutical Ingredients
Inspections and audits
The established and integrated management system for quality, safety and environmental protection ensures compliance with national and international regulations thanks to ISO 9001 and ISO 14001 certification and meticulous documentation and procedures, which are verified by external and internal audits.
We have successfully passed a large number of inspections by the FDA, international and national authorities – a recognition of our commitment and a guarantee of success for our customers
- FDA (Food and Drug Administration, USA)
- EMA (European Medical Agency)
- TGA (Therapeutic Goods Administration, Australia)
- PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
- COFEPRIS (Federal Commission for the Protection against Sanitary Risks, Mexico)
- ISO 9001 & ISO 14001 audits
- Frequent customer audits
Health, Safety and Environment (HSE)
Our integrated management system for HSE
Protecting our workers, installations and the environment is a priority at Proquina. This is why we are always committed to continuously improving our high standards in aspects such as process and plant safety.
Proquina maintains a comprehensive integrated safety program oriented toward processes and facilities as well as employees and contractors. It focuses on the prevention of accidents and incidents, with the aim of protecting personnel, facilities and materials, and promoting a culture of safety among its employees.
To meet this goal, Proquina has a highly trained and qualified HSE team in charge of preventing and responding to all sorts of situations that could endanger employees, the environment and the facilities.