Our company’s quality policy is to manufacture and produce medicines which have effective results and, high and assured quality, to meet the needs of customers through using advanced technology based on drug researches and market study of the drug industry. Under this policy and to see effective results, we aim to implment innovative and efficient management to reach sustainable improvements and developments in compliance with relevant regulatory policies and procedures and the GMP standards.
- To respect needs of customers and produce medicines based on scientific researches and approaches in compliance with relevant laws, regulations and standards on pharmaceutical manufacturing operation.
- To implement quality control system effectively and conduct monitoring based on conformity and relevant data.
- To conduct surveys and researches on customer satisfaction and quality of medicine and to perform required monitoring.
- To analyse issues highlighted by external and internal audits to assess quality objectives prior to develop plans.
- To execute regular training to improve leadership in work place and to give opportunities to employees to gain more professional knowledge.
The division is responsible for quality validation based on quality verification processes, from raw materials to final products, on quality of raw materials, manufacturing conditions, manufacturing process levels, health and safety of employees, and production equipments in accordance with national and international pharmacopeia, norms and technical requirements.
- Control on raw materials
Active pharmaceutical ingredients/raw materials (API) /Photo of packaged raw materials and GMP certificate/ Raw materials are supplied from manufacturers complied with GMP requirements domiciled in China and South Korea. In accordance with registration and recording procedure, raw materials listed and registered at the state registration are used for manufacturing. Regular auditing and assessments are conducted to manufactures of suppliers.
- Control on packaging
Packaging of raw materials are thoroughly inspected in accordance with MNS 5524-2014 standards for goods manufacturing practices for pharmaceutical products prior to order and accept ordered products locally or abroad.
- Control on manufacturing process
- Production process control
Pharmaceutical professionals conduct control on production process starting from raw materials to final products in line with MNS 5524-2014 standards for goods manufacturing practices for pharmaceutical products for verification.
- Drug examination
Drug examination is took place in an accredited laboratory which opened in 2005 in compliance with ISO 17025 standards. The laboratory has accredited by the Mongolian Agency for Standardization and Metrology four times since the implementation of the ISO standards. Also, the laboratory operates in line with MNS ISO17025-2007 standards for examinations and quality controls on raw materials and packaging through its professional personnel and advanced technologies.
- Health and safety assessments
Under the health and safety assessments, regular control is taken to ensure environment where production took place and employees work is safe and secure based on advanced and microbiological traditional approaches. Also, regular control is taken place to make sure employees meet the requirements and given standards.
- Production process control
- Sustainable quality researches, expiry date and transportation
- Drug safety and market researches
Quality verification process takes place after control on manufacturing and documentations prior to quality verification manager authorizes the products to be introduced to market.
Control on stability of active ingredients of finished pharmaceutical products within expiry date is taken place in accordance with MNS 6439-2014 standards for general requirements for stability testing of active pharmaceutical ingredients and finished pharmaceutical products. Expiry date control is conducted monthly basis through using ERP program when storage and transportation are managed by FIFO systems.
Quality, safety, monitoring and market research are conducted regularly in accordance with the plan for assessment.