Quality system

The Quality Unit consists of two parts: Quality Control (QC) and Quality Assurance (QA). QC primarily ensures the use of compliant starting materials and products, sets appropriate analytical specifications for each manufacturing stage, and performs all analyses. QA is mainly responsible for reviewing and approving company processes and batch-record documentation, conducting audits, trending results and releasing finished products.

QA/QC/RA

The quality of the products manufactured by our company is further assured by an implemented quality assurance system that meets the current requirements of ISO 9001 and Good Manufacturing Practice for active pharmaceutical ingredients (cGMP). Because the quality system connects every department—from purchasing to finished-product release—through the manufacturing process, its active maintenance is an important part of our corporate culture.

The Quality Unit also emphasises incorporating the latest cGMP, ISO and ICH requirements into the company system to make the fullest possible use of modern quality management tools.

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