Good Manufacturing Practices (GMP)
Both the Drug Regulations and the NHP Regulations have specific requirements for Good Manufacturing Practices (GMP). Both frameworks outline basic requirements for drug and natural health products (NHP) GMPs within the regulatory framework. More detailed requirements or expectations are then published in various interpretative guidelines.
The goals of GMP are to establish the following:
- Ensure that drugs and NHPs are manufactured, packaged, labelled, tested, or stored in an environment which does not compromise the product’s safety or efficacy.
- That personnel with adequate training and expertise are available to carryout, supervise or approve various GMP activities.