Good manufacturing practices, GMP for short, are measures and procedures designed to ensure consistent product quality and safety for all facilities manufacturing, processing, packaging, labeling and distributing products. In Canada, GMPs must be followed for all category of products: Drugs, Foods, Natural Health Products, Medical Devices, Cosmetics, Veterinary Products, Radiopharmaceuticals and Biological products. GMPs are similar across product categories, in that they address the following quality standards concerning:
Premises, Equipment, Personnel, Sanitation, Raw Material Testing, Manufacturing Control, Quality Control, Packaging Material Testing, Finished Product Testing, Records, Samples, and Stability.
GMP requirements in Canada are similar to those in other countries such as the EU, Australia, Japan, and United States. However, we must remember that the product category (NHP, cosmetic, food, etc) dictates the level of GMP required by the Regulations in that specific country.
For example, a product considered a “food” in Norway falls under the “natural health product” in Canada due to the ingredients and product delivery format (capsule format, for instance). In this example, the food quality standards in Norway are followed during production, but once that product is destined for the Canadian market, it will need to have more robust quality testing in order to meet the Canadian Regulations.
The key to successfully complying with the quality standards of any country is to first know what category your products fall under. This applies to foreign companies wanting to enter the Canadian market, and vice-versa, but also important to consider if you are a Canadian manufacturer or a Canadian importer.
Speaking of Canadian importers… the Canadian company is responsible for that product once it has entered Canada. As a result, regardless of the product category, importers should be sure that the products they are intending to import meet the appropriate Health Canada Regulatory requirements. Often a Quality Technical Agreement (QTA) is put into place between the foreign manufacturer and the Canadian importer to ensure all GMP requirements are met.
Our team of Quality Assurance experts can help you through the process by categorizing your products accordingly (country-specific), advise where there are any gaps in meeting the GMPs for that category and help fill those gaps by implementing the necessary quality protocols and drafting QTAs. Contact us today to learn how we can help you become GMP compliant.