The Quality Control Unit according to GMP (Good Manufacturing Practices) is located on the ground floor of the Codivilla-Putti Research Centre.
The main equipment has been subjected to IQPQOQ and critical parameters are controlled through a continuous monitoring system.
The laboratory performs microbiological analyses in the clinical field as well as quality controls for the Rizzoli Musculoskeletal Tissue Bank and other facilities that produce or operate in asepsis or in controlled contamination environments. It also participates in studies, research activities and clinical trials, developing and providing specific quality controls in the biological and microbiological fields.
In addition, it performs biological, microbiological and chemical/physical tests according to European Pharmacopoeia and is able to develop and validate quality control methods for specific types of samples or processes, tissues, cells, radiopharmaceuticals, reagents.
The services can be provided by trained professionals both to internal laboratories and units of the Institute and on behalf of third parties.
Microbiological analyses for the detection of osteomuscular infections are performed for patients of the Rizzoli Operating Units, applying specific protocols defined by national and international guidelines.
The laboratory cooperates with the Clinical Risk Management department of the Institute in mapping risks, in particular the biological risk of the IOR controlled contamination environments.
In this connection, the Institute is also HUB at regional level in the treatment of complex orthopaedic pathologies, in particular osteo-articular infections and hospital infections.
The absence of microbial contamination of the final product is supported by assays performed to validate and monitor the production process in all its phases. The Laboratory is able to provide consultancy for risk assessment and the development of a Quality Control plan.
The GMP Quality Control areas have been designed and built in compliance with current building and laboratory safety regulations: in particular, the Microbiology area is physically separated from the areas dedicated to other Quality Control activities (Cytofluorimetry, Molecular Biology, Tissue Microbiological Control, Cell Microbiological Control).
The laboratory is ISO 9001:2015 certified. It was also authorised by the Italian Drug Agency (AIFA) to perform quality control for advanced therapy medicinal products of the Rizzoli Cell Factory from 2010 to 2017. In these years it has gained a deep experience in quality control in compliance with Good Manufacturing Practice (GMP) standards and the European and Italian Pharmacopoeia.
Contacts and Locations
The Quality Control Unit according to GMP
e-mail: firstname.lastname@example.org; email@example.com
Rizzoli Orthopaedic Institute
via G.C.Pupilli, 1
40136 Bologna, Italy