Quality Control
QUALITY The quality control of medical devices, pharmaceuticals and food supplements in order to guarantee the highest product and process quality constitutes an essential part of our quality management process. We check whether primary and secondary packaging materials are regulation-compliant and analyse raw materials and products across all stages of production – from bulk solution to finished product.
METHODS Our highly qualified team combines modern instrumental analysis (e.g. HPLC, UV-VIS, FTIR, rheology, refractometer, tensiometer) with traditional wet chemical methods. Method development, transfer and validation are as much a part of our repertoire as the verification of pharmacopoeial methods. In our newly established microbiological laboratory, we carry out bioburden testing and analyse environmental monitoring data.
LIFE-CYCLE We manage our products for their entire life cycle: our experts develop test plans, store stability samples and carry out both quality tests and in-use stability tests, as well as the associated preparation of reports. We process the batch releases of medical devices as well as the releases of pharmaceuticals by a qualified person (QP).
We guarantee the highest quality without making concession in terms of flexibility and punctuality! We believe in fast and effective communication both internally and externally – this enables us to give the best advice and respond to the individual needs of our customers.
If you are interested to take advantage of our services, please contact:
projects@mono.co.at
Tel: +43-(0)1-330 0671-0
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