Quality control – Nikopharm

Quality control

Manufacture of medicinal products leads to the certain obligations. Our company is responsible for effectiveness and safety of the products being  manufactured and guarantees their compliance with the registration dossier requirements.

To meet the above obligations, the company established a quality system which guarantees the quality of each product pack of the batch released.

The company’s quality system deals with ensuring the product quality starting from its development and research, then going to raw materials’ purchase, production and quality control, further storage and finally giving all necessary information to a doctor and a patient.

This guarantee is assured through the following aspects:

  • qualified personnel and efficient program of personnel training
  • availability of the premises and equipment which fit to the production process
  • usage of the proper raw materials of high quality
  • in-process control
  • control of raw material, semi-finished product and final product
  • proper storage and transportation
  • availability of the efficient documentation system

The company’s quality system operation is ensured by Quality Service which consists of the following departments: Quality Control Department, Quality Assurance Department, Validation Department and R&D Department.

To fulfill its professional duties, the Quality Control Department is provided with the laboratory which in its turn includes chemical lab and microbiological lab to control product’s sterility and microbial purity.


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