In 2004, pursuant to the decision of Pharmsynthez PJSC management, Enterprise Quality Management System (QMS) was developed, formalized and implemented. The QMS is currently being maintained and continuously improved in conformity with ISO 9001:2000 standard of Requirements to Quality Management System, GOST R ISO 9001:2001 standard of Requirements to Quality Management System and GOST R 52249-2004 on Regulations of Medicines Production and Quality Control.
Company QMS is based on the following underlying principles:
- Customer orientation.
- Management leadership.
- Employees involvement.
- Professional approach.
- Systematic approach to management.
- Continuous improvement.
- Decision making based on factual data.
- Mutually advantageous relations with suppliers.
- manufacture of principal pharmaceutical products (active pharmaceutical substances and officinal medicines);
- manufacture of organic chemicals (organic intermediary products).
- Main QMS processes:
- Documents and records management.
- Management responsibility.
- Resources management.
- Product life cycle.
- Measurement, analysis and improvement.
The above processes are headed by appointed responsible persons. Processes effectiveness criteria have been developed.
Pharmsynthez PJSC General Director has assumed responsibility for implementation of QMS and ensuring its continuous improvement. Personally or through a Quality Management Representative, the General Director controls and evaluates effectiveness of QMS and measures aimed at its further perfection, monitors progress, takes corrective and preventive steps and otherwise ensures QMS continuous improvement.