The site licensing system within Canada requires that all manufacturers, packagers, labelers, and importers be licenced. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements.
Good Manufacturing Practices for Natural Health Products
Good Manufacturing Practices (GMPs) must be employed to ensure product safety and quality. They require appropriate standards and practices regarding product manufacture, storage, handling and distribution of natural health products (NHPs). For Natural Health Products, the provisions cover:
• specifications (product)
• premises
• equipment
• personnel
• sanitation program
• operations
• quality assurance
• stability
• records
• sterile products
• lot or batch samples, and
• recall reporting
The GMPs are designed to be outcome based, ensuring safe and high quality products while giving manufacturers, packagers, labelers, importers and distributors of NHPs the flexibility to implement quality systems appropriate for their product lines and businesses.
