The Centre for Comparative Medicine and Bioimage (CMCiB) of the Germans Trias i Pujol Research Institute, a CataloniaBio &HealthTech member, has been awarded the certificate for complying with good laboratory practices (GLP) in line with the European Directive 2004/9/CE. The centre complies with the principles established by the Spanish Royal Decree822/19932 for carrying out preclinical studies with healthcare products (analytical tests, clinical chemistry - haematology and biochemistry - in studies administrating trial products, obtaining samples and biocompatibility of healthcare products). The areas certified are the surgical and bioimage areas, including the technology of vascular radiology interventions, ultrasound scan and magnetic resonance.
This certificate, awarded by the Government of Catalonia, guarantees the quality and integrity of the results of the research laboratories that carry out preclinical studies. The regulatory milestone demonstrates that the CMCiB adheres to international research standards. Since 2021, the legislation requires that medical devices, such as prosthetics, catheters, valves, stents and surgeries etc. are preclinically validated under the GLP certification before initiating clinical trials.
To obtain this certification, the CMCiB has included three more quality control professionals on its staff and the Quality Guarantee Unit of FalcoQuality has provided support. This took the form of training for personnel on the principles of GLP, advice on the implantation process and the execution of all the actions in the quality guarantee programme. The team of professionals at the CMCiB has been working for the last year and a half to implant the quality system. The certificate obtained helps to situate the CMCiB-IGTP as a reference centre for carrying out preclinical trials for medical devices in the conditions required by the regulatory agencies, helping companies with the process of bringing this type of product to market.
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