Laboratory Wellness: A Prescription for Consumer Safety

2011-10-05

For the millions of Canadians that take medication each day, the potential for wellness begins first in a laboratory.

The practices adopted in laboratory facilities that conduct manufacturing, testing and safety studies—for products produced by pharmaceutical and cosmetic companies—have a direct effect on the health and safety of Canadian consumers.

Those facilities that adhere to the principles of Good Laboratory Practice (GLP) prescribed by the Organization for Economic Cooperation and Development (OECD) are better equipped to ensure that high quality and reliable test results are being generated, in a consistent manner. Laboratories dealing with data pertaining to the safety of industrial chemical substances, and to preparations for harmonizing of testing procedures, must be especially attuned to concerns of accuracy and reliability.

Since the mid-1970s, the OECD has been a driving force behind the usage of GLP, encouraging laboratories to meet their full potential of providing reliable, accurate services. Consisting of 34 countries in North America, Europe and Asia, the OECD is an inter-governmental organization that provides governments with a forum to share experiences and seek solutions to common problems in order to understand what drives economic, social and environmental change. Among the areas it has championed is the pursuit of international harmonization in testing methods and good laboratory practices.

In Canada the regulatory authority responsible for minimizing the risks associated with the distribution of drug and health products, is Health Canada. Through the Health Products and Food Branch, Health Canada regulates how these types of products make their way from the laboratory into the marketplace.

Health Canada fulfills Canada’s obligation to the OECD, of compulsory monitoring, by making GLP adherence an essential legal prerequisite for sectors that are well studied, supported and standardized, both by industry and its regulatory counterparts internationally. As such, it supports GLP implementation and the international acceptance of non-clinical safety data generated in Canada for pharmaceuticals, radiopharmaceuticals and biologics.

According to Stephane Shank, Media Relations Chief of the Public Affairs, Consultation and Communications Branch at Health Canada, adhering to GLP adds significant value for laboratories hoping to build a reputation for properly testing products such as medication.

“GLP compliance makes good business sense because it ensures consistency in the production of non-clinical studies in Canada, which in turn, increases the international competitiveness of the Canadian drug industry,” says Shank.

He contends that although the process is rigorous, the rigor is necessary to help avoid a cascading chain-reaction of negative effects. “Although it’s a resource and time-intensive task for all stakeholders,” says Shank, “failures in quality systems can affect many products and companies simultaneously, and are very difficult to resolve.”

In April of 2010, Health Canada released its final guidance document on mandatory compliance to GLP for all Canadian facilities generating non-clinical study data in support of applications involving pharmaceutical, radiopharmaceutical or biologic drugs for human use. The Standards Council of Canada (SCC) is the actual Monitoring Authority designated by Health Canada for assessing the GLP compliance of Canadian test facilities. SCC also, represents Canada in the OECD GLP Working Group.

In its assessments SCC reviews virtually all managerial aspects of the studies conducted by those facilities—from the planning stage, through to archiving and reporting results—and including work conducted in the laboratory and in the field. Given that compliance with OECD GLP principles helps to ensure studies performed on Medical products and chemicals are carried out according to internationally accepted requirements, recognition by SCC under the GLP initiative facilitates acceptance of studies in other OECD member countries.

Although it is a mandatory requirement in Canada for specific types of testing facilities, many Canadian facilities have also come to appreciate the business value and extended market access of adhering to OECD GLP.

Algorithme Pharma (AP), which conducts over 275 clinical trials annually, has also adhered to GLP since their creation in 1996 for pre-clinical studies. Because AP requires pre-clinical studies to be accepted outside of Canada, in member countries that fall under the auspices of the OECD, GLP is a must.

“Clinical studies are required by drug regulatory agencies in every country around the world. These studies ensure that any medication taken by Canadians is safe and does its job properly,” says Fabio Garofolo, Vice President of Bioanalytical Services at Algorithme Pharma.

“GLP recognition opens up doors for us to deal with clients at different stages of their drug development,” explains Garofolo. “This ultimately leads to increased opportunities for proposals and increased sales revenues,” he explains.

Garofolo concurs that the process of being GLP recognized is indeed rigorous and thorough. He describes the four-day experience as intense, but adds that it “was very positive due to the open and forthright approach followed (by SCC).”

Ultimately, the recent mandatory requirement that all Canadian facilities generating non-clinical study data be GLP compliant has affected AP in a positive way. According to Garofolo, improvements made to the industry as a whole have been beneficial to their laboratory. He attributes the confidence and trust that AP has established with their clients and agencies, and in their studies, with the mandatory requirement to be GLP compliant.

GLP-compliant Canadian facilities reap all of the inherent benefits of adhering to a system that addresses the organizational processes and conditions under which pre-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported. Ensuring the wellness of laboratory practices by using GLP-compliant facilities is a clear way for Canadian companies operating in the pharmaceutical and health industry to ensure efficiency, credibility and market access while protecting consumer safety and to ensure their studies are accepted by the other OECD member countries.

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