Recent Enforcement Actions Highlight Need for Proper Auditing of Contract Laboratories

January 22, 2013 By

By: William Morkel, BSc Director of Quality & Compliance

Recent closure of a testing laboratory in Mississauga, Ontario by Health Canada illustrates the need for companies to audit third party/contract testing facilities to ensure best practices are being followed.

Unlike laboratories engaged in the testing of drugs, laboratories involved in quality control testing of natural health products (NHPs) are not required to hold an Establishment Licence or a Site Licence. In fact, the NHP GMPs say very little about laboratory standards or requirements. This, however, does not absolve manufacturers, importers and/or product licence holders of their responsibility of auditing their laboratories, third party or otherwise, to ensure they are competent and qualified.

The importance of exercising such due diligence was highlighted a month ago when Health Canada actually shut down a lab in Mississauga, Ontario after they uncovered evidence that the lab was falsifying test results1,2. This came in the wake of a tip that the Inspectorate received from a whistleblower who was employed with the laboratory and that was confirmed during a follow-up audit. The lab in question was involved in testing NHPs, among other health products.

As a result, many of the companies who had engaged the services of this lab have had to suspend sales of the affected lots and are now having to retest their products. Therefore, not only do these companies have to bear the costs of immediate corrective and preventative actions, but they must also bear the bad publicity. All of the companies, along with their affected products, were named publically both on Health Canada’s website and in media coverage of the story. Ironically, these companies are among those who are at least making an active effort to comply with GMPs and product testing requirements at a time when there are still some in the industry who are negligent in these areas.

While the details behind the lab shutdown remain to be investigated fully, the lesson to industry is clear – make the effort to thoroughly audit your vendors in advance. The NHP GMP guidelines require that manufacturers, packagers, labelers, importers, and distributors “Ensure that laboratories (in-house and contract) are capable of performing all of the tasks and responsibilities assigned to them”3. While this requirement is vague, and guidance from the NHPD in this area is limited, there are some important questions that one should ask when initially considering a laboratory:

  • How long have they been in operation?
  • Are they periodically audited or accredited by an independent third party?
  • Do they have experience testing your types of products?
  • Are lab staff qualified to test your type of products?
  • Do they have sufficient numbers of staff and is there fast staff turnover?
  • What is their compliance history?
  • Do they subcontract any work?
  • Do they have references?
  • Are key equipment items duplicated? (For example, do they have only one HPLC – if so, where will that leave you if it breaks down?)

The above list is by no means exhaustive. Moreover, although not explicitly required by the current NHP GMPs, an on-site audit of the lab is highly recommended. One may ask, “If the lab is already audited by Health Canada or another independent party, why should I conduct my own audit?” Bear in mind that the lab in Mississauga, that was recently shut done by Health Canada, underwent periodic government inspections. Conducting your own audit allows you to focus on your particular product(s) and on the particular lab systems, procedures, equipment, people, and practices that may impact the testing of those products. Labs should never be judged on pricing or turnaround times alone. The money you save now may have to be paid back later, with interest, through costly damage control measures.

At dicentra, we have a team of regulatory experts that can conduct an independent third party audit of a testing laborartory that you wish to employ. We can be reached at 1-866-647-3279 or


  1., Health Canada suspends Mississauga lab over falsified drug test results, Jeff Green, December 4, 2012,
  2. Health Canada, Advisories and Warnings. Health Canada Suspends Licence of Chemical Testing Laboratory For Providing Falsified Results, December 4, 2012,
  3. NHPD Good Manufacturing Practices Guidance Document, Version 2.0, Available at: