Natural Health Products
site licensing services
Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production from the starting materials, premises, and equipment to the training and personal hygiene of staff. Detailed written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made. 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 and non-prescription health products (NNHPs). For Natural and Non-prescription 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.
ADVERSE REACTION ReportING
Natural health products are often made from plants, but can also be made from animals, micro-organisms and marine sources.
Natural health products, often called "complementary" or "alternative" medicines, include:
vitamins and minerals
traditional medicines like Chinese and Ayurvedic (East Indian) medicines
other products like amino acids and essential fatty acids
All authorized natural health products have a: Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)
Site LicenCE APPLICATIONS
The site licensing system requires that all manufacturers, packagers, labellers, and importers be licensed. 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.