The Quality Department consists of two parts – Quality Control (QC) and Quality Assurance (QA). QC ensures the use of compliant raw materials and products, the setting of adequate analytical specifications for each stage of production, and the performance of all analyses. The main responsibilities of QA are controlling and approving business processes, reviewing records, auditing, trending results, and releasing finished products.
The quality of the products made by our company is further assured by the quality assurance system that has been implemented and which meets the current requirements of ISO 9001 and Good Manufacturing Practice for the manufacture of active pharmaceutical ingredients (cGMP). The quality system connects, through the manufacturing process, all the departments in the Company, from purchasing up to the release of the finished product, and its active development is an important part of our corporate culture.
The Quality Department also emphasizes the implementation of the latest findings of cGMP, ISO, and ICH regulations into the company system in order to maximize the use of modern quality management tools.
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ISO_9001_Farmak_CZE.pdf (207 kB)
ISO_9001_Farmak_ENG.pdf (197 kB)
Acreditation certificate of foreign manufacturer - PMDA.pdf (49 kB)
GMP CERTIFICATE_2022.pdf (200 kB)
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