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Module:  3.
Novel bioproducts development and validation in an operational environment
Unit:  3.3.
Bioproducts (incl. fisheries and aquacultures) validation in an operational environment

Bioproducts (including those of fisheries and aquacultures) for human or veterinary use are subject to validation in an operational environment in order to ensure safety and quality standardization. This is outlined in detail in a series of guidelines and procedures that apply to the stages of development and processing, the employment of reference standards and validated analytical assays, all stages of process control (from development to commercialization) and quality characterization (specifications). The bioproducts (including those obtained from fisheries and aquacultures) must be extensively characterized at development and processing stages to define strict specifications in terms of physicochemical properties, biological activity, immunochemical properties, purity, impurities and contaminants. They need to meet certain predefined acceptance criteria and match reference standards and validation of analytical procedures. The fish side streams used for human grade food, must be handled and controlled in the same manner as the primary products to ensure the proper quality and safety. That is why food safety and quality control systems are applied, including Hazard Analysis and Critical Control Point (HACCP) and Good Manufacturing Practice (GMP).


Anna Kujumdzieva, Evgeniya Dimova-Karagyozova (R&D Center Biointech Ltd)

Basic training