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Olpha ensures high quality standards in product design, development,
production, testing, control and distribution, which guarantees the highest
quality of manufactured products and services, allowing patients to improve
their health and stay healthy.
Ensuring the quality of our products begins with the careful selection of raw materials. The intermediates used in our production meet strict requirements and they are produced at Olpha or purchased from qualified manufacturers/partners.
The finished product is produced in accordance with the requirements of the relevant registration dossier and using modern technologies and equipment.
During production, quality control of intermediate products is carried out to ensure obtaining a high-quality final product.
The products are sealed in high-quality packaging, protecting the medicines from the effects of the surrounding environment and ensuring the quality of the products during their storage.
Quality control laboratories are moving towards digitalisation in order to optimise processes and ensure a high level of traceability and compliance with ALCOA+ data integrity requirements. We have started implementing the LIMS project.
Our staff participates regularly in internal and external training, which allows to raise the ever-evolving professional level and follow modern trends.
We work with reputable and stable long-term partners that meet the highest standards of corporate governance. At all levels of process management, we choose only proven partners, according to the norms of international law. Olpha has developed and implemented a procedure for checking partners, which is regularly improved and revised in order to meet all the current requirements of regulatory acts and the company’s internal policies.
European Union Good Manufacturing Practices, Eurasian Economic Union Good Manufacturing Practices, US FDA approval, and Certificates of Conformity are a mark of quality that is valued by our partners around the world. The company has a multi-level quality control system, the laboratories have implemented a quality system according to GMP and ISO/IEC 17025 requirements. Sanitary-ecological laboratory is accredited according to ISO/IEC 17025.