What is Control and Quality assurance ?

Every manufacturer must have a control and quality assurance system to conform to the Canadian Good Manufacturing Practices (GMP).

Quality assurance is a wide-ranging concept that covers all matters that individually or collectively influence the quality of a drug. It is the total of the organized arrangements made with the objective of ensuring that drugs are of the quality required for their intended use. Quality assurance therefore incorporates Good Manufacturing Practices, along with other factors that are outside the scope of these guidelines.

A system of quality assurance appropriate for the manufacture of drugs should ensure that:

How are they regulated in Canada ?

Title 1A, Part C of the Food and Drug Regulations defines the activities for which compliance with good manufacturing practices must be demonstrated before a site licence is granted.

Who is aimed by this regulation ?

And if I don’t comply with this regulation ?

Any drug must be manufactured in accordance with the Canadian GMPs under a valid site licence. If Health Canada have reasonable reasons to believe that a drug was manufactured under conditions which does not conform to the GMPs, it can requires with the manufacturer to withdraw the product of the market and also, in some cases, to suspend the site licence to the manufacturer.

What can we do for you ?

Our team of experts can assist you to build a control and quality assurance system which conforms to the Canadian GMPs.

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