Good Manufacturing Practice, GMP refers to the manufacturing practice for products used in medicine, medical devices or active pharmaceutical products, from development to availability on the market. These guidelines follow country legislations and aim at safeguarding the health of the patient. In Belgium, the competent authority responsible for the quality, safety and efficiency of medicines and health products is the Federal Agency for Medicines and Health Products (FAMHP).
The facility benefit from ISO17025 quality assurance system of the CART. In November 2011, the Mass spectrometry laboratory was audited by the FAMHP and received the agreement for qualitative proteomic analysis.
This agreements covers the activity of the proteomics platform.
In practice, this means that the facility can perform analysis of raw material for GMP producers and deliver a certificate of analysis for qualitative analyses such as :
- Complex mixture protein identification by ESI-LC-MSMS after trypsin digestion.
- Mass determination of protein and peptide by Mass spectrometry.
Other specific analysis can be performed or developed under request.