McGowan Institute for Regenerative Medicine
While quality systems, such as U.S. FDA Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) are an integral part of the safety testing and manufacturing of medical products ranging from pharmaceuticals to medical devices, they are rarely used in the basic research that leads to the technologies that permit the products to be manufactured and brought to the marketplace. The majority of this basic research is conducted in academic laboratories. One exception to this practice is that some academic laboratories that focus on clinical applications implement quality assurance (QA) system principles that reflect or are compliant to regulations such as Good Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices.
There is a growing recognition that for the early stage (basic) research there is a need for improved tools and guidance to facilitate the maintenance of the integrity and reproducibility of the data collected. In the last ten years, the McGowan Institute has taken a lead role in the adaptation of Good Research Practices (GRP) by developing Quality Management Systems (QMS) “fit for the purpose” within the Center for Preclinical Studies (CPCS). This initiative is currently the only research unit within the University of Pittsburgh operating under a functional QMS, capable of performing medical device safety studies to meet FDA regulatory testing standards.
Based on our experience with the establishment of the McGowan QMS, it was recognized that substantial benefit could be realized. We have found that the implementation of these principles fosters an environment that produces scientific outcomes with a higher degree of reproducibility and traceability thus leading to overall improvement in the integrity of the data produced. The intent of this project that was supported by the First Nonprofit Foundation funding was to assist in developing, implementing and validating a fully functional Quality Management System; in essence to bring to fruition a project started ten years ago.
Ultimately the patients by the expedited development and delivery of advanced bio-medical technologies. In the short-term, the primary beneficiaries are scientists and the funding agencies whose mission it is to translate new biomedicine to the clinic.
Also, having the availability of Quality Management solutions in research environments will help stretch the research dollar further. Considering what quality management principles promote when appropriately implemented, it provides a culture where the potential for error is limited. And when errors do occur (and they will) the opportunity to perform root cause analysis is possible because critical steps in the process were carefully documented by qualified personnel. So, in the overall scheme of things, one can easily make an argument that projects such as this help everybody– From those funding the research assuring that their dollars will be used wisely– through to the patients, who are the primary beneficiaries.
This work has resulted in an academic biomedical research lab that has reaffirmed and demonstrated the advantages of QMS for basic research, enhancing the stature of the McGowan Institute, and serves as a demonstration site to facilitate broad implementation of QMS in an academic environment.
Expedited assessment of new and emerging biomedical technologies and procedures, and demonstration that QMS are beneficial in an academic research environment.