Handbook for Understanding and Implementing the Containment Analysis and Critical Control Point Plan for the Production of Plant-Made Pharmaceuticals and Plant-Made Industrial Products
This Containment Analysis and Critical Control Point (CACCP) plan supports the production of plant-made pharmaceuticals (PMP) or plant-made industrial products (PMIP) in transgenic plants.
A number of host plant systems are being utilized for the production of PMPs and PMIPs including alfalfa, lemna, maize, rice, safflower and tobacco. Each host plant system has unique characteristics that are favorable to the production of PMPs and PMIPs; each system also requires well-defined and controlled containment procedures to ensure the integrity of production and to prevent release and propagation of the transgenic plant outside its controlled manufacturing operations.
The CACCP plan is based on the precepts embodied in Hazard Analysis and Critical Control Point (HACCP) approaches and was prepared in accordance with US Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition (CFSAN) examples and guidance from the Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) on HACCP plans for the food industry.