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The McGowan Institute of Regenerative Medicine Received a Grant to Implement Quality Management Systems at Their Academic Laboratories

In any laboratory environment, accuracy is of utmost importance. The ability to recreate a result is more important than having created it in the first place. And, when it comes to scientific research, any variable can compromise the integrity of the study’s findings. That’s why the FDA requires a series of standardized practices be put in place before any approved medical treatment can be used by the public. These practices are monitored by Quality Management Systems (QMS).

It’s common for basic research for medical products to begin in academic settings, namely universities. But when breakthroughs are made at a university laboratory, it often takes a long time for these findings to make their way to a production stage because most university labs don’t have QMS in place. That’s why the McGowan Institute of Regenerative Medicine, a partner of the University of Pittsburgh, received a grant from First Nonprofit Foundation to implement a QMS at their academic lab—so that their findings can be documented in a standardized manner and new medical discoveries can reach patients as quickly as possible.

What is a QMS?

Specific procedural documentation is needed in order for a medical discovery to reach its way to the marketplace. Before a medical product can be made available to the public, it must first undergo a series of tests to prove that the results can be recreated. This is important to assess both the potency and the potential risks of a new drug or medical procedure.

Specific reports are needed to prove the integrity of the data. This is where a Quality Management System (QMS) comes into play. A QMS is a formal system designed to standardize a given procedure in order to produce predictable outcomes. In this case, the outcome being measured is the effect of biomedical technologies.

Why is QMS Important?

Evidence from more than a decade’s worth of studies has proven that the use of QMS greatly improves the traceability, and therefore the integrity, of the data produced from a lab. It is for this reason that the Food and Drug Administration (FDA) requires that certain QMS be put in place in order for medical products to reach the marketplace, as a means to protect patients. Examples of QMS required by the FDA include:

  • Good Laboratory Practices (GLP)
  • Good Research Practices (GRP)
  • Good Manufacturing Practices (GMP)

All of these practices were put in place in the 1960s after some mistakes during the development or production of pharmaceuticals (or other medical products) led to patients being harmed or killed. By standardizing and regulating certain aspects of the medical industry, the products that people rely on for their health are subjected to a series of tests, so that they’re proven to be safe for use.

How Do QMS Requirements Relate to Academic Laboratories?

At the McGowan Institute for Regenerative Medicine, a grant was given by the First Nonprofit Foundation to put QMS into place at the academic lab level. By incorporating QMS into academic lab environments, any research projects that are developed there have a better chance of reaching the people who need them in a timely manner. This is partly because academic QMS reduces the need to replicate experiments due to data integrity issues.

Rolling out the QMS at McGowan didn’t happen overnight. The need for such standardization has been evident for some time and McGowan’s efforts to implement them has been 10 years in the making. The McGowan Institute has taken a lead role in developing QMS that meet the needs of their Center for Preclinical Studies (CPCS). With the help of the grant money, McGowan has been able to fully execute the project that’s been in the making for over a decade.

The CPCS at McGowan has been working on advancing organ engineering research to the point that they have begun discussions with the FDA to pursue approval to conduct a human clinical trial. This advancement is partly thanks to the lab’s QMS.

Potential for the Future

By incorporating QMS in academic research environments, new and emerging biomedical technologies and procedures can reach patients faster. Since McGowan started using QMS at their lab, they have demonstrated the benefits that such procedures can bring to an academic environment. These benefits are evident through the integrity of their findings and the efficient manner in which discoveries can reach the market. With any luck, McGowan will set the new standard for academic laboratories and pave the way for expedited medical discoveries.