Dietary supplements

     Dietary supplements - despite product forms typical of medicines - are qualified as food. Sites involved in food production are under the supervision of the State Sanitary Inspectorate. Each food plant, on the basis of an inspection, is entered into the register of units under the supervision of this authority. The basis for approval is compliance with hygiene requirements set forth in the Food and Nutrition Safety Act of August 25, 2006 and Regulation (EC) No. 852/2004 of the European Parliament and of the Council of April 29, 2004 on the hygiene of food stuffs. Each site is also required to implement and maintain a HACCP system, based on hazard analysis and critical control points. Inherent points of this system are GMP, or good manufacturing practice, and GHP, or good hygiene practice. These are the so-called pre-programs, or actions that must be taken and hygienic conditions that must be met and controlled at all stages of production or sales to ensure food safety.

GHP

     GHP, or good hygiene practice, is the fulfillment of proper sanitary and hygienic requirements that take into account the organizational structure and specifics of an establishment's operations. GHP requirements include: the location, surroundings and infrastructure of the plant, buildings and the functional layout of the premises, machinery and equipment, washing and disinfection processes, water supply, waste management, pest control, staff training and hygiene, and record keeping and documentation.

    Food production facilities must be located in places that do not adversely affect the safety and quality of products and production processes - the outdoor area should be protected from unauthorized access and animals, the surface paved to prevent the formation of stagnant water, vegetation maintained in good condition - so that contamination from the surrounding environment does not pose a threat to products. Buildings must be made of suitable materials, and the layout of the premises is to prevent cross-contamination. Storage, production and social areas should be separated. The routes of raw materials and finished products should be clearly defined. The correct functional layout of the plant should also ensure that the technological processes and the flow of raw materials, packaging materials, semi-finished products and finished goods run smoothly. It is also very important to ensure proper temperature and humidity conditions in production and storage areas.

     The hygiene of food production is also determined by machinery and equipment. Production sites should be equipped with machines and appliances made of suitable materials. All the equipment should be maintained in good condition and cleanliness. All surfaces of machinery, plant and equipment in contact with the product should be made of material approved for contact with food, durable, smooth and easy to keep clean. All machines and equipment should be designed and manufactured to ensure that they can be effectively washed and disinfected.

     Chemicals suitable for the food industry should be used for cleaning and disinfection. Cleaning processes must be defined and validated, and their effectiveness continuously monitored. This has a direct impact on the health safety of food.

     Water used in a food plant must meet the relevant requirements set by law. Its quality should be systematically controlled.

    Waste management in a food plant, in addition to compliance with the law, should ensure product safety. Waste should be systematically removed from production spaces, stored in appropriate places, protected from pests.

   Pests can pose a serious microbiological as well as physical threat to food. The most common pests include rodents, flying and running insects, or birds, cats and other pets. The plant should be monitored for the presence of pests. Pest surveillance is most often outsourced to specialized third-party companies.

    Among the most important factors directly influencing food safety are hygiene and personnel training. Food safety-conscious employees, regularly trained in hygiene accordingly to their activities, duties and competencies, take part in ensuring the safety of manufactured products. Therefore, it is very important to build and maintain food safety culture in a food plant. The basis for achieving strong food safety culture is the availability of resources: locker and social room equipment and hygiene facilities.

‍

Summary

     GMP, or good manufacturing practice, alongside with GHP, defines the conditions for producing safe food. It covers the receipt of raw materials and supplies, storage and handling of raw materials, pre-processing and basic processing, internal transportation, storage of finished goods, and external transportation and distribution. Food warehouses must be designed and constructed in a way that enables food protection from contaminants and pests, that enables cleanliness and order, ensures temperature and humidity conditions that guarantee the preservation of the highest health and nutritional quality of food, ensures proper segregation of different types of food and the rotation of products in the warehouse: the FEFO principle is used - first in, first out or FIFO - first in, first out. Materials should be received into stock in a way that guarantees full traceability and food safety. They should be inspected on entry and subject to analysis, the results of which guarantee safety and compliance with specifications. Internal transportation should ensure proper protection of transported raw materials, semi-finished and finished products from microbiological, physical and chemical contamination.

     The so-called pharmaceutical GMPs, or general good manufacturing practice requirements, apply to manufacturers of medicinal products that are under the supervision of the Chief Pharmaceutical Inspector. There are special requirements regarding the admission to trading for medicinal products, however good manufacturing practices are basically the same as in GMPs and GHPs in food production. Nevertheless, dietary supplements and food stuffs for special nutritional purposes cannot be produced under the pharmaceutical GMP standard, without the supervision of the State Sanitary Inspector.