Application of good manufacturing practices in the production of food products for special medical purposes

Abstract

In order to guarantee the proper quality of medical products and medicines, the mandatory application of Good Manufacturing Practices (GMP) norms in almost all countries is provided by law. Given the importance of nutritional provision of human portrebs in emergencies, the use of GMP is also relevant in the production of food products for special medical purposes. The object of research is the methodological base, approaches, and norms of GMP application in the manufacture of this product category. It is determined that the implementation of these practices is ensured mainly through measures for raw materials, equipment, personnel, premises, compliance with hygienic requirements, journaling, internal control, response to complaints, monitoring, traceability, product recall. It is established that the basic principle of GMP application is the production of products that will meet the purpose and provisions of the registration dossier. At the same time, ensuring product quality is a comprehensive concept of ensuring compliance with properties, combining organizational measures at all stages. This activity should be carried out taking into account risk-oriented thinking based on the control of raw materials, packaging, testing in the production and release of goods to the declared characteristics, ensuring high competence of personnel, process and analytical validation. Recommendations on a set of measures aimed at introducing good manufacturing practices at enterprises producing food products for special medical purposes have been compiled and presented. The essence of these recommendations is to identify technological processes, monitor their implementation, provide the necessary resources and measures, establish the process of documenting actions, validation at all stages, including self-inspection.