Quality and commitments
Total quality management
Our production units are run by skilled and dedicated staff. Our production equipment is modern, fitted with the latest technologies. We apply Good Manufacturing Practices (GMP). Manufacturing takes place in a controlled environment, with strict checks on raw materials and finished products throughout the process.
Certifications
Our quality management system is certified to the following standards.
- ISO 9001
- Quality management systems.
- ISO 15378
- Primary packaging materials for medicinal products: the standard adds Good Manufacturing Practice to the requirements of ISO 9001.
What these standards require
ISO 9001
It covers the way work is done, not the product. It requires processes to be defined, responsibilities assigned, deviations recorded and addressed, and the whole reviewed periodically. A conforming product obtained by luck does not satisfy it; a process able to reproduce it does.
ISO 15378
It takes ISO 9001 and adds Good Manufacturing Practices, transposed to the articles that touch the medicine. To these it adds risk management, change control — a supplier does not unilaterally alter an article listed in a medicine’s dossier — and traceability down to the raw material batch. This is the standard a pharmaceutical buyer cites when qualifying a primary packaging supplier.
Good practices and controlled environment
Good Manufacturing Practices do not describe a level of quality but a discipline: write down what you do, do what you wrote down, and be able to prove it afterwards. Every batch leaves a trail that allows anyone, months later, to trace back to the material used and the machine settings. A controlled environment, for its part, means a workshop where particulate contamination, temperature and access are managed and measured — not for the workshop’s sake, but because a particle settling inside a bottle will stay there all the way to the patient.
Environment, health and safety
Our commitment to protecting the environment is total, and it is the natural extension of our quality approach. Hygiene is a requirement in our day-to-day operations, and safety has become second nature.