Quality System
«Quality is above everything, everyone has benefits from quality»...
Guaranteeing of permanent high quality of the manufactured products and rendering services is provided by the quality management system, operating at the enterprise in accordance with the requirements of the ISO 9001 international standard and the Good Manufacturing Practice (GMP) branch standard, which takes into consideration the requirements of the World Health Organization in respect to products to be sold or distributed within the territory of origin and export countries.
The quality policy is an integral part of the general policy at "INDAR" CJSC and the basis for the Quality Management System.
We guarantee high and constant quality of the manufactured products and rendered services via complex and systematic solution of tasks for provision of quality at all stages of product life cycle:
The quality assurance system, premises and equipment meet the requirements of the EU Good Manufacturing Practice (GMP), recommendations of the Cooperation System for Pharmaceutical Inspections (PIC/S) and the World Health Organization (WHO), in respect of products to be sold or distributed within the territory of Ukraine the EU countries, which is proved by the GMP National Certificate.
The main elements in "INDAR" CJSC currently used Quality Management System are:
- the corresponding infrastructure or the quality system at the enterprise, including organization structure, methods, processes and resources;
- multi-level documented Quality Assurance System based on the principles of the Good Manufacturing Practice (GMP), the Good Laboratory Practice (GLP), the Good Clinical Practice (GCL) and the Good Distribution Practice (GDP) and applied to all the stages of products manufacturing influencing its quality, starting with design, experiments and registration up to the moment of its prescription to patients.
The enterprise's Quality Assurance System guarantees that:
- the manufactured products are developed and researched according to the GMP, GLP and GCP requirements;
- the order of putting the products for manufacturing was observed: all the state registration procedures were fulfilled in accordance with the legislation in force, permissions for their medical usage and the Registration Dossier were received;
- technological and supportive processes and works for quality control were clearly defined, documented and correspond to the good manufacturing practice;
- batch incoming inspection of the starting materials, auxiliary and packing materials is documented and also the production process is controlled, which helps to identify and track each batch of the manufactured products;
- the program for validation of processes and methods of analysis is fulfilled according to the Master-plan in order to receive the additional guarantees for achieving the expected results from methods, process, equipment, raw materials, activity and system;
- certain measures are taken to save the quality of the ready products during their storage, distribution and further delivery and selling to consumers;
- product recall system was created for rapid recalls of the sold volumes of products in cases of reclamations and complaints;
- self-inspection and audits are held for regular evaluation of the efficiency and appropriateness of the management and quality assurance systems and corresponding correcting and preventive actions for increasing their efficiency.