Farmastur’s Quality Unit assures that the products manufactured under cGMPs are obtained in a homogeneous way, are suitable for their usage and do not involve any risk for their users.

Farmastur has been approved by the FDA for the manufacture of sterile sodium sulbactam and its blend with sodium ampicillin.

Quality Assurance

QA is responsible for the supervision of cGMP manufacturing of every API or intermediate in Farmastur facilities, guaranteeing that cGMP regulations are fully respected.

Quality Control

QC activities comprise the whole quality system field related to sampling, tests and documentation, which guarantees the fulfilment of all the necessary and appropriate tests for the final products.

Farmastur QC 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.

· QC activity implies both the chemical and microbiological fields

· QC department has personnel devoted to the development and validation of the necessary analytical methods, both in the chemical and microbiological areas.

©Farmastur 2010