Quality Assurance

Quality Assurance is responsible for the quality system cGMP referring to everything concerning, individually or collective, the quality of the manufactured product. It guarantees the cGMP regulations are respected.

Quality Control

Quality Control comprises the whole quality system field related to sampling, tests and documents , which guarantees the fulfilment of all the necessary and appropriate tests for the final products.
Asturpharma Quality Control laboratories possess the technical means, qualified personnel and the needed approved methods in order to fulfil the required controls of raw materials, intermediates, in-process and final products, as a way of guaranteeing that they are not to be used until their quality has been approved according to the established quality regulations.

Quality Control activity implies both the chemical and microbiological fields.
· The chemical area relies on the appropriate analytical instruments (HPLC, GC, UV, FT-IR, TOC...) to carry out the physical and chemical controls of their products.
· The environmental monitoring of the sterile production rooms, the microbiological analysis of raw materials as well as final products are carried out in the microbiological area.
This department has personnel devoted to the development and validation of the necessary analytical methods.