The old adage, “The job’s not finished ‘til the paperwork’s done,” is turned on its head when it comes to a Health Canada Drug Establishment License (DEL), where no job starts until the paperwork is done. Health Canada requires anything that might serve as medical treatment — whether it is a pharmaceutical drug or device — be produced and tested according to specific standards. These standards are defined by Good Manufacturing Practice (GMP) and, before an organization can be granted a DEL, it must meet or exceed the expectations of Health Canada auditors.
In this light, it is easy to understand William Leigh’s excitement about his department’s newly minted DEL. As chair of the Department of Chemistry and Chemical Biology at McMaster University in Hamilton, Ont., part of his responsibility lies in overseeing one of the largest nuclear magnetic resonance (NMR) spectroscopy labs in the country, a site with no fewer than eight instruments equipped for a wide range of analytical activities.
For many years pharmaceutical companies have regularly sought out the capability and expertise of these McMaster facilities in support of their research and development projects. However, analytical data that is obtained outside the rigorous controls of GMP can be used for R&D purposes but not for quality control of drug products heading to market. The new DEL and accompanying designation of the McMaster analytical labs as a GMP-testing facility means that the data they acquire can be integrated directly into a much wider range of their industry clients’ activities.
Leigh regards the Health Canada certification as a major step forward for Canadian academic laboratories. More specifically, he regards the DEL as a practical means of ensuring that these research platforms can continue to flourish and grow in the face of increasing budgetary pressures. It also benefits students, who get a first-hand look at the kind of regulated environment where they may spend their careers, he says. “Many students go on to work in GMP environments and it’s to their advantage to understand what this means before they graduate. Every summer student, every grad student and every post doc has to go through a GMP orientation session where the nuts and bolts of the system are explained to them so they gain a fundamental understanding of the concept of a GMP lab.”
Although the technical staff at McMaster have long been aware of the need for more extensive quality certification that would make it possible to expand the external services they could offer to industrial clients, the push to obtain the DEL really got underway in 2013. The work fell to a seven-member team led by quality manager Dan Sorensen, whose previous experience at drug giant Merck gave him invaluable knowledge of the processes and expectations demanded by the industry. Sorensen admits that setting up a GMP lab from scratch was new territory for him and argues that the result has given the research facility new horizons for its academic and industrial work. “The overall success of the project was very much due to the team effort,” he says. “Passing the audit is testament to the fact that we built a unique quality management system with procedures based upon our combined practical experiences that reflected what we actually did, rather than setting standards that we couldn’t meet.”