In order to strictly comply with all necessary conditions and requirements in the production of pharmaceutical products, the quality management system has been developed and organized in the “Remedy Group” JV LTD. The Quality Service at the company is represented by the Quality Assurance Department (QAD) and the Quality Control Department (QCD).
The Quality Control Department is a structural subdivision independent from the production that performs continuous control over compliance with the requirements of the national and international standards. The department includes two testing laboratories: physico-chemical and microbiological, equipped with modern laboratory equipment.
Premises of QCD laboratories are designed and divided into zones, depending on the tasks performed in them, taking into account the flow of processes carried out in them.
QCD laboratories have regulatory documentation, laboratory equipment, reagents, reference and test samples, consumables required for all the necessary research.
QCD conducts incoming inspection of raw materials, in-process control in the manufacture of medicines and control of finished products.
Basic principles and priorities of the QCD
• Issuance of reliable data on the quality of raw materials and finished products;
• Continuous improvement of the technical and regulatory framework;
• Continuous improvement of the competence of specialists;
• Continuous improvement of the system based on both our own and international experience;
• Improvement of control methods;
• Documentation of all tests and operations performed.
The main functions of the QCD
• Incoming control of incoming raw materials (medicinal substances – substances), primary packaging materials (vials, ampoules, foil and PVC film for blister molding), secondary packaging materials, including printed products (labels, cases, instructions for medical use);
• Control during production:
• At each stage of the technological process, control points are determined, from which the selection of an intermediate product is carried out to confirm compliance with the established requirements;
• Studying the stability of drugs and the process of storing archival and control samples;
• Development of measures to eliminate and prevent the release of defective products;
• Sampling of raw materials, intermediates and finished products;
• Control of the sanitary condition of production and storage facilities, workplaces and equipment;
• Monitoring compliance with storage conditions in warehouses for raw materials and finished products;
• Taking part in the selection of suppliers of raw materials and materials;
• Development of specifications for feedstock and materials, intermediate products, finished products