Health Canada issued a guidance document on Good Manufacturing Practices (GMP) which pertains to Part 3 of the Natural Health Product Regulations (the Regulations) and is intended for manufacturers, packagers, labellers, importers, and distributors of natural health products (NHPs) for sale in Canada.
As per section 27 of the Regulations, manufacturers, packagers, labellers and importers are required to hold a valid site licence. The site licence holder is responsible for ensuring that activities being conducted at the site are being conducted in accordance with GMP, as outlined in Part 3 of the Regulations.
The document provides guidance to facilitate compliance with the good manufacturing practices (GMP) outlined in part 3 of the Regulations. In addition, this document is a tool for the Quality Assurance Person (QAP) to implement and maintain GMP and to fulfill their role in assuring the quality of a NHP before and while it is made available for sale.
The Natural and Non-prescription Health Products Directorate (NNHPD) recognizes that there are various ways of meeting the GMP and producing safe and effective NHPs. For example, specific methods to achieve GMP compliance in sanitation may vary with the particular operation. This guidance document sets out GMP requirements; however, they are not regarded as the only interpretation of the Regulations. Alternative means of complying with the Regulations will be considered by the NNHPD when an appropriate rationale or justification is provided.
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