Quality
Top quality every day
Our medications help countless people lead longer, better and more active lives every day. We must ensure that every Polfarmex medicine that reaches your hands is effective and safe to use.
How we achieve this
- We strictly follow the rigorous standards of Good Manufacturing Practice (GMP).
- We constantly refine our processes. We analyse internal audit findings and enhance our quality management system.
- We ensure that all employees understand and recognise the impact of their work on the quality of the medications we produce. We elevate our qualifications through internal and external training programmes.
- We invest in modern machinery, which allows us to produce safely, with continuous monitoring of the manufacturing process.
- We use the latest laboratory devices to precisely analyse the parameters of our medications.
Pharmaceutical Quality System
We ensure the quality of our medicines at every stage of production: from sourcing raw and packaging materials, through storage, production, packaging and labelling, to the storage and distribution of finished products. This is why we base our work on the Pharmaceutical Quality System. This system guarantees that the medicinal products we produce meet all the necessary requirements before they reach pharmacy shelves: they are effective and safe.
Good Manufacturing Practice
Good Manufacturing Practice (GMP) is the combination of effective procedures, control and oversight throughout the production process. Adhering to GMP procedures guarantees that our medicines are produced under conditions that allow for the manufacturing of products meeting the stringent quality requirements for pharmaceuticals.
Quality risk management
This is an ongoing process of monitoring and evaluating all actions that contribute to the production, storage and availability of a medicine for patients. It encompasses not only the actions that have occurred but also the anticipation of events that could potentially affect the quality of the medication in the future.
Did you know…?
At Polfarmex, the quality of our medicines is overseen by 83 specialists from the Quality Assurance, Validation, Quality Control, Microbiological Laboratory and Qualified Persons departments.
Our quality management system comprises 9,000 documents, detailing every action taken within the company.
Continuous quality control
Patient safety is our top priority. Therefore, we check the quality of our medicines 24 hours a day, according to Good Laboratory Practice standards. This is made possible by combining the expertise of our specialists with the capabilities of modern equipment for conducting chemical and microbiological analyses.
Quality control verifies that all raw materials and components used in our drug production meet the specifications we have approved, and that the manufactured medications possess the properties required for market authorisation.
We confirm compliance with requirements for:
- active pharmaceutical ingredients (API), excipients and intermediates used in drug manufacturing,
- direct and printed packaging materials such as labels, cartons and leaflets,
- finished medicinal products – ensuring they retain their properties throughout their shelf life.
Quality confirmed by certifications
Every Polfarmex medicine is produced according to the strict standards of Good Manufacturing Practice (GMP). This system is based on production, control and quality assurance procedures that guarantee that the products meet specific quality requirements. The Good Manufacturing Practice certificate is an official confirmation that the manufacturing conditions comply with Good Manufacturing Practice requirements.
Our certifications
Storage and distribution
Every journey of active substances and materials used to create our medications, and the finished products waiting to be shipped to wholesalers and pharmacies, begins and ends in the central warehouse. We ensure that our products are stored and distributed under the proper conditions, with controlled temperature and humidity.
The Polfarmex central warehouse operates in compliance with Good Distribution Practice (GDP). This confirms that, as a manufacturer, we provide safe conditions for the storage, transportation and distribution of our medications.
Did you know…?
The Polfarmex central warehouse covers 3,800 square metres, with 7,500 pallet spaces in a high-rack storage system up to 10 metres high.