Focus on production quality or uncompromising GMP compliance
In accordance with the requirements of the pharmaceutical quality system and good practices for the production, preclinical and clinical research, distribution and sale of medicinal products (GMP, GLP, GCP, GDP, GPP), the quality of the drug is established at the stage of pharmaceutical development, is ensured at the stage of production and is guaranteed during the entire shelf life and life cycle of the drug.
In this regard, one of the main criteria for the quality of a medicinal product is its microbiological purity, because the permissible presence of a minimal number of non-pathogenic microorganisms and the absence of pathogenic microflora guarantees the stability of the drug throughout its shelf life, provided that the storage conditions determined at the stage of development and indicated on the package.
Conversely, microbiological contamination of a medicinal product leads to the deterioration of its quality characteristics under the influence of the products of microflora’s vital activity: the dosage form becomes unstable, the active substances are destroyed, their quantitative content decreases, there is an uncontrolled accumulation of unwanted impurities, which ultimately leads to a decrease or even the absence of therapeutic effectiveness, and sometimes to the point that the drug becomes dangerous for medical use. At the same time, neither a doctor, nor a pharmacist, nor a patient is able to independently identify such a danger without conducting a full analysis of the quality of the drug in specialized physico-chemical and microbiological laboratories.
That is why it is impossible to ensure the quality of medicines without complying with the requirements of good manufacturing practice, which takes into account all the risks that in one way or another affect the quality of each unit of the released products, especially their microbiological purity.
We guarantee product quality
The company has developed and implemented an integrated quality management system certified in accordance with the requirements of GMP, DSTU ISO 9001:2015, DSTU ISO 13485:2018, DSTU ISO 22000:2019, DSTU EN ISO 22716:2015, DSTU ISO 45000:2019, DSTU-N CAC/RCP 1:2012 (HACSR).
One of the important elements of the quality system at pharmaceutical enterprises, including Viola FF, is quality control.
The objects of control are raw materials, packaging and auxiliary materials, semi-finished products, finished products, sanitary and hygienic conditions of production and personnel.
Conducting reliable physicochemical and microbiological quality control is impossible without the availability of appropriate laboratory premises, modern laboratory equipment, documentation and competent personnel.