The Company creates its Quality System based on the principles of national and international (GMP EAEU) Good Manufacturing Practice rules, ICH Q10 (Pharmaceutical Quality System) and other current pharmaceutical regulatory documents in accordance with Sun Pharma procedures. The Company's commitment to implementing a reliable and sustainable Quality System is achieved through the continuous promotion of the production improvement and quality compliance culture, meeting the expectations of our customers, stakeholders and regulatory authorities.
The Quality Control Department of PJSC “Biosintez” is responsible for incoming quality control of pharmaceutical substances, excipients, packaging materials and printed products, in-house control and quality control of finished products, as well as monitoring the production environment.
The QC Department of PJSC “Biosintez” employs more than 150 employees having the required education, qualifications, level of knowledge, professional skills and work experience to implement proper control.
The QC Department has laboratories for in-process control of sterile and non-sterile medicines, a chemical analytical laboratory, a bureau for instrumental methods of analysis, a microbiological laboratory, a pharmacological laboratory, a bureau for quality control of packaging material and printed products, a bureau for stability studies and drafting regulatory documents.
The Laboratories are equipped with state-of-art equipment that allows testing raw materials, medicines, etc. to confirm the compliance with the quality indicators established in the regulatory documents.

The Quality Assurance Department maintains and develops the Quality System principles in all production areas.
A team of qualified employees is involved in risk analysis, internal audit, work with suppliers and customers, deviation management, confirmation of the validation status of facilities.
The Department is furnished with all the required equipment for the qualification of clean rooms and utilities systems.