Quality Control System

  • The Company has a properly implemented, documented and maintained Integrated Quality Control System compliant with the requirements of GMP ЕС.
  • The basic document in Company’s Quality Control System is the Quality Manual comprising the Director-approved Quality Control Policy defining resources, staff responsibilities and processes ensuring functionality of the Quality Control System.
  • The responsibility for efficient functionality of the Quality Control System is held by the Deputy Director in Quality Control – an Authorized Person.

 QUALITY POLICY


Lumier Pharma determined the provision of Ukrainian residents with effective, high quality, and safe medicines compliant with present-day market needs, to be the top priority of its business.
In order to achieve the established mission, the company’s management has set the following objectives:

  • Product quality placed at the number one position. Maximum satisfaction of customer needs in terms of product quality.
  • Constant analysis of pharmaceuticals market trends.
  • Production activities in the frame work of an integrated quality management system developed in strict compliance with EUGM Prequirements.
  • Dynamic development and improvement of the quality management system.
  • Building up partners’ understanding of their role in securing the high quality of manufactured products.
  • All types of activities of personnel, suppliers and partners are integral parts in the product creation process.
  • Stimulation of employee involvement with the processes that secure high product quality; application of motivation principles in labor; fostering optimal psychological climate in the work environment.
  • Securing timely detection and, more importantly, prevention of undesirable issues and errors, analysis of their reasons and determining a set of corrective and preventive measures to be taken towards the elimination of such reasons.

The company’s personnel – the main nexus in the chain of effort towards the set goal – is aware of the goal and objectives regarding attaining high quality of products and offers suggestions concerning the improvement of the company’s operations.


The company’s management guarantees the initiation of the adopted Quality Policy and due control of its implementation, as well as the prevention of errors in the enterprise’s daily activities.
 

In order to secure the proper performance of set tasks and of the established Policy, the company’s management undertakes to provide all necessary resources and take any expedient steps directed at the improvement of staff’s qualifications.


Required from every employee is complete understanding and promotion, as well as striving towards flawless and efficient performance, of their functions in line with the established policy and the respective field of activities.