What's News at Nucro-Technics

The Importance of Choosing a Qualified Contract Laboratory

by Constantine on December 4, 2012

The following information update was released by Health Canada today:

OTTAWA – Health Canada has suspended the Establishment Licence of Chemi Pharmaceutical Inc. of Mississauga, Ont., after uncovering falsified testing results during the course of an inspection.

Health Canada is verifying the nature and use of testing done by Chemi Pharmaceutical Inc. with the company’s customers. Our survey of clients to date indicates that only a portion of the company’s work involved testing of final products before they entered the Canadian market.

However, as a precautionary step, companies that have had testing done by Chemi Pharmaceutical are being asked to temporarily halt sales of those products until their safety can be confirmed.

Source: Health Canada Information Update 2012-184

How important are your testing results?  Health Canada recently revoked the Establishment Licence of a Mississauga-based testing laboratory during a surprise inspection that was the result of a phone tip.  At least fifty-three products from eleven companies are affected.  These companies have been asked to halt sales of their product until their safety can be confirmed.  As of December 4, 2012, confirmations are still pending on the course of action that needs to be taken for another twenty-five products owned by eleven other companies.

Thankfully, this type of situation is not very common but it does show the importance of choosing a good laboratory to conduct any testing that is being outsourced.  Because the contract lab is an extension of your business, the Canadian product licence holder is ultimately responsible for the results.

So what should a product licence holder be looking for when it comes to selecting a contract laboratory? There are three elements that are important:

  • An ability to conduct the testing at the appropriate quality standard;
  • A good regulatory and corporate track record; and
  • An ability to communicate well.

NUCRO-TECHNICS is a full-service Contract Support Organization that conducts its testing to the appropriate quality standards that are requested by its clients (GMP / GLP).  Our full-service laboratories cover a range of contracted research & development in Pre-Clinical Toxicology, Genetic Toxicology, Bioanalytical Services, Analytical Chemistry and Microbiology.  Our employees possess more than 2,000 years of combined experience in everything from routine testing to creating new methods and procedures for the latest pharmaceutical innovations.

NUCRO-TECHNICS is pleased to say that our track record spans more than 40 years and over that time, we have conducted work for the 10 largest pharmaceutical companies in the world.  We are routinely audited by Health Canada, the FDA, as well as the Standards Council of Canada.  We also hold accreditations and designations from ISO and various other organizations.

As well as being audited by regulatory agencies, we are also routinely audited by our clients – on average 80 times a year.  We have our own internal audit program that is run by individuals that are independent of the areas being examined.  These internal and external inspections help us to continuously improve our services and make NUCRO-TECHNICS the better choice.

While no laboratory is perfect, we strive to continuously improve our offerings through good customer service, by communicating honestly with our clients, and by being flexible to the needs of our customers.

For further information about these services, to receive a quotation, or to schedule a test, please contact us.

Sources:

Health Canada Information Update 2012-184: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_184-eng.php

Health Canada Media Advisory:  http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_184lt-eng.php#a2

CTV News Article: http://www.ctvnews.ca/health/health-canada-suspends-ontario-chemical-testing-lab-1.1065203

Toronto Star Article: http://www.thestar.com/news/canada/politics/article/1297401–health-canada-suspends-mississauga-lab-over-test-results

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