Pharmaceutical Quality Control and a Recent Recall

At the end of May, four companies announced a recall on five drugs commonly sold in Canada. The recall is not about a problem with the medications themselves, as a treatment.  Amlodipine, ciprofloxacin, norfloxacin, lamotrigine and telmisartan are all still considered to be safe and effective in their own right. Instead, the recall affects only certain batches and lot numbers. This issue provides a case study for pharmaceutical quality control from the manufacturing side of things.

No pharmaceutical company wants the bad publicity of a recall, but this incident also shows the necessary redundancies in pharmaceutical quality assurance. In this particular instance, the problem goes all the way down the supply chain and outside the country. After an inspection by European Directorate for Quality of Medicines & Health Care the agency advised Health Canada. We’re still waiting on the full report from the European agency, which examined the manufacturing processes of an Indian company, Smruthi Organics Limited.

The Effect of the Recall on the Canadian Pharmaceutical Industry


Every single level of the manufacturing and clinical research process provides its own oversight. This applies to everything from base ingredients, to the conditions under which they are transported and stored, to the mixing and packaging process, and even how products are handled in pharmacies. External agencies, like the European Directorate for Quality of Medicines & Health Care, are entities that help an industry with numerous companies working together on a single end product co-ordinate their efforts for consumer safety.

On the bright side, there are adequate amounts of unaffected versions of the five recalled drugs, so patients will not be unduly harmed or unable to get their prescriptions filled. The four companies behind the drugs and Health Canada also caution patients using these medications not to cease their regular doses. In cases like this, consumers can rely on a well-designed plan make sure there’s supply redundancy, so there’s easy access to batches that have a complete seal of approval.

This problem has already triggered a long-term effect. Indeed, since it originated outside of Canada, it has created a public desire for more manufacturing steps to take place in Canada, which in turn may mean more jobs for skilled pharmaceutical professionals. That gives you even more reasons to brush up on everything from HPLC training to international manufacturing standards.

What other effects do you think this recall is going to have?


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