PSK Pharma’s Mission is to work for the benefit of society, enhancing the quality and longevity of patients’ lives.
In the context of modern development, the term „quality„ is viewed as a comprehensive concept encompassing the quality of pharmaceuticals, processes, supplies, resources, and more. It fundamentally characterises the culture of production and quality within the company.
Our quality strategy is based on the standards of good practices, collectively referred to as “GxP", and is implemented at all stages of the product life cycle: from pharmaceutical development to commercial production, including multi-stage quality control.
Quality control is a crucial component of our quality strategy. Incoming inspection ensures the quality of raw materials and substances used in pharmaceutical production. In-process control focuses on process parameters and the quality metrics of intermediate products. Every batch of finished pharmaceutical products undergoes a release quality control procedure in accordance with the specifications outlined in the regulatory documentation for the medicinal product.
Our commitment to expanding our portfolio of pharmaceutical products and technological innovations is also reflected in our quality aspects: our laboratories are equipped with advanced, sophisticated analytical equipment that enables the implementation of modern quality control methods. Processes are measured and continuously improved, and the competencies and expertise of our employees, as the company’s core values, are maintained at a high level of professionalism.
We are uncompromising when it comes to quality and aspire to lead the Russian pharmaceutical market by providing consumers with high-quality, effective, and safe medicinal products!
Laboratories
Physico-Chemical Analysis Laboratory
In our laboratories, every aspect of laboratory operations is crucial to achieving accuracy, reliability, and timely measurement results.
| The Physico-Chemical Analysis Laboratory is equipped with state-of-the-art, high-precision analytical instruments from leading global companies such as Agilent, Waters, Perkin Elmer, and others: |
| 50 high-performance liquid chromatographs (LC) |
| 3 gas chromatographs |
| 2 automatic dissolution testers |
| 3 next-generation impactors |
Additionally, a laser diffractometer, an X-ray diffractometer, an IR spectrometer, automatic titrators, and more.
This array of equipment allows us to conduct a wide range of analytical research, including biotechnological studies, on our premises. Our laboratory specialists possess the highest level of expertise, independently developing and validating complex analytical methods used to investigate the quality characteristics of pharmaceutical samples. They work with biorelevant media and conduct comparative dissolution kinetics tests, enabling the prediction of clinical trial outcomes.
The Physico-Chemical Laboratory at PSK Pharma is currently the only laboratory that most competently performs in vitro testing of inhalation drugs, both in aerosol and powder forms, thanks to our unique next-generation impactors (NGI).
The Impactor study replicates all seven compartments of the human lungs, enabling the precise determination of the active substance quantity penetrating the lungs during inhalation (particle sizes ranging from 1 to 5 microns). This is a crucial characteristic of the specified pharmaceutical forms. For particle size distribution analysis, a state-of-the-art Sympatec instrument is employed, allowing for the rapid assessment of the raw material quality used in the manufacture of inhalation forms.
The laboratory’s activities also encompass the development, validation, and subsequent application of analytical methodologies within the framework of cleaning validation. In this context, we work with microdoses of the target substance, necessitating highly sensitive methods and flawless precision in execution.
Furthermore, we have developed and successfully applied tests for leachables and extractables from filters, as well as from closure systems and equipment parts that come into contact with the pharmaceutical product. These tasks are crucial for validating sterilising filtration and for stability studies of medicinal products.
Microbiological Analysis Laboratory
The guarantee of obtaining reliable test results is ensured by a combination of high specialist qualifications, modern equipment, precise method replication, effective process management, and adherence to pharmaceutical quality system standards. Microbiological Laboratory of LLC "PSK Pharma"
| The Microbiological Laboratory of LLC "PSK Pharma" is licensed to store and work with microorganisms of pathogenicity groups III — IV. The laboratory conducts a wide range of tests, including: |
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All testing methodologies used undergo verification/validation procedures.
Testing is conducted on qualified equipment.