We buy the best world specimens of technological, packing and laboratory equipment which allow to improve quality of finished products, their consumer properties.
We have successfully modernized manufacturing facilities for aerosols in accordance with international requirements of Good Manufacturing Practice (GMP).
In modernization of facilities, the most modern materials and technologies are used.
All manufacturing facilities are equipped with devices which provide strict control over quality of produced products.
As a responsible manufacturer, we assign quality of products already on the first stages of production cycle (developments, studies), track it in the manufacture process and strictly control prior the release.
At the plant, the system of quality assurance is set up which function reflects a modern approach of the management to organization of the plant’s activity, in particular manufacture, quality control, beneficial cooperation with external organizations.
Comprehension of responsibility for quality of produced products obliges us to improve constantly the manufacture process in accordance with national and international standards of pharmaceutical manufacture, including GOST Р 52249-2009 Good Manufacturing Practice for Medicinal Products (GMP)), GOST Р 52537-2006 ‘System of quality assurance. General requirements”.
Ideology of GMP standard implies transfer from batch control of finished products to quality assurance in all manufacture stages. One of the most important aspects of manufacture organization in GMP is the professional training of staff, as the plant modernization and establishment of clean room facilities is impossible without relevant staff training. Staff training for activity in GMP standards is targeted on forming staff orientation for quality. On the plant, the system of internal training is established which is taken by all the staff involved in activities which can affect quality of finished products. Forms of external training are used with involvement of leading national GMP specialists. Formation of responsibility in employees, increase of motivation and involvement to manufacture process allows to reduce risks and minimize discrepancies and products of inadequate quality. Formation of understanding of the role and responsibility for quality of produced products in employees is of great importance for the plant.
At the plant, the document management system is implemented and constantly being improved which is regulated by the plant standard and allows to:
- check adequacy of documents prior the release;
- analyze documents and actualize them as required;
- provide identification of changes and status of reviewed documents;
- provide the relevant versions of documents in application areas;
- keep documents in clear and identified form;
- revent unintended use of outdated documents and identify correspondingly such documents left for any purposes.
Special attention is given to management of production registration entries (flow charts), which allow to track and analyze all circumstances which are related to manufacture of an individual batch of medicinal product.
Validation measures in the plant are carried out in accordance with validation policy and validation master plans. All methods of analytical tests, equipment and facilities, manufacture and cleaning are certified (validated). All results of certification are documented. The drug manufacture uses only certified processes.
To evaluate compliance of quality assurance system to GMP rules and quality of its function on the plant, an internal audit (self-inspection) is made in approved schedule. Procedures of self-inspections and presentation of results are regulated by the plant standards which allow to take timely measures for elimination of identified deficiencies. The well-balanced policy of internal audit allows to expel fears in workers of the plant and stimulate openness and initiativity of the staff having a direct impact on quality. All reclamations and information about products with assumed quality deficiencies which come to the plant, are registered and thoroughly analyzed. Any reclamation obtained by the plant from participants of drug circulation or individuals is not left without answer and adequate enquiry.
For detection and elimination of discrepancies, the plant has implemented discrepancy management system. The discrepancy management system allows to detect timely and record discrepancies, make analysis of identified discrepancy and define and plan actions (corrective actions and measures) according to the results of discrepancy analysis and its identified causes. All decisions on the identified discrepancy are to be documented, which allows to analyze efficiency and efficacy of corrective actions and prevent discrepancies in future.
Constant clarifications and discussion of quality assurance concept and further use by each employee, and explanation of infeasibility of formal execution of the instructions by employees provide strict observance of norms and rules which are adopted at the plant. So skilful combination of perfectionism policy and non-formal approach, together with strict observance of all GMP principles allows to maintain quality standards at the plant on the highest level.