Everything you need to know about GMP Good Manufacturing Practice

Anna Racławska
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Czego się dowiesz po przeczytaniu tego artykułu

- Under whose supervision are the plants producing dietary supplements

- Can a plant producing dietary supplements have pharmaceutical GMP

- What is GMP

- What is GHP

- What factors affect the safety of food and dietary supplements

Czego się dowiesz po przeczytaniu tego artykułu

- Under whose supervision are the plants producing dietary supplements

- Can a plant producing dietary supplements have pharmaceutical GMP

- What is GMP

- What is GHP

- What factors affect the safety of food and dietary supplements

Dietary supplements

Dietary supplements — despite the product forms typical of medicines — are qualified for food. Food production facilities are under the supervision of the State Sanitary Inspector. Each food establishment, on the basis of the inspection carried out, shall be entered in the register of establishments supervised by that authority. The approval shall be based on compliance with the hygiene requirements laid down in the Act of 25 August 2006 on food and nutrition safety and Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs. Each plant is also obliged to implement and maintain a HACCP system, based on hazard analysis and critical control points. Inherent elements of this system are GMP, i.e. good manufacturing practice and GHP - good hygiene practice. These are the so-called preliminary programs, that is, the actions that must be taken and the hygienic conditions that must be met and controlled at all stages of production or marketing to ensure food safety.

Programy wstępne jako podstawa systemu HACCP.
Figure 1. Preliminary programs as the basis of the HACCP system.

GHP

GHP, or good hygienic practice, is the fulfillment of the appropriate sanitary and hygienic requirements taking into account the organizational structure and the specifics of the activity of a given establishment. GHP requirements include: the location, environment and infrastructure of the plant, buildings and functional layout of premises, machinery and equipment, washing and disinfection processes, water supply, waste management, pest supervision, training and hygiene of personnel, and the maintenance of documentation and records.

Food production facilities must be located in places that do not adversely affect the safety and quality of the products and the production processes — the external area should be protected from the access of unauthorized persons and animals, the surface paved to prevent the formation of stagnant water, the vegetation maintained in good condition — so that pollutants from the surrounding environment do not pose a threat to the products. The buildings must be made of suitable materials and the layout of the premises is to prevent the occurrence of cross-contamination. It is necessary to separate the warehouse, production and social zone. The routes of raw materials and finished products should be clearly defined. The correct functional layout of the premises of the plant should also ensure the non-collision course of technological processes and the flow of raw materials, packaging materials, semi-finished products and finished products. It is also very important to ensure proper temperature and humidity conditions in the production and storage rooms.

The hygiene of food production is also determined by machinery and equipment. The plant should be equipped with equipment and equipment made of appropriate construction and finishing materials, which are maintained in good technical condition and cleanliness. All surfaces of machinery, equipment and equipment in contact with the product shall be made of a food-safe material that is durable, smooth and easy to clean. All machinery and equipment shall be so designed and constructed as to ensure the possibility of effective washing and disinfection.

Maszyny wykonane ze stali nierdzewnej.
Fig. 2. Machines made of stainless steel.

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

The water used in a food establishment must meet the relevant requirements established by legal regulations. Its quality should be systematically checked.

Waste management in a food establishment, in addition to compliance with the law, should ensure the safety of products. Waste should be systematically removed from production premises, stored in appropriate places, protected from pests.

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

Hygiene and staff training are among the most important factors that have a direct impact on food safety. Employees aware of food hazards, regularly trained in the field of hygiene in accordance with their activities, duties and competences, participate in ensuring the safety of manufactured products. Therefore, it is very important to build
and maintaining a culture of food safety in the food establishment. The basis for achieving a high culture of food safety is the availability of resources: equipment for changing rooms and social rooms, and hygiene points.

Figure 3. Adequate preparation for production work.

summary

GMP, or Good Manufacturing Practice, defines the conditions for the production of safe food next to GHP. Includes the adoption of raw materials
and materials, storage and handling of raw materials, preliminary and primary processing processes, internal transport, storage of finished products and external transport and distribution. Food storage facilities must be designed and constructed in such a way as to protect food from contamination, to maintain cleanliness and order, to protect food from pests, to provide temperature and humidity conditions to guarantee the highest quality of health and nutrition of food, to ensure adequate segregation of different types of food and rotation of products in the warehouse: the principle of FEFO — first expired, first out or FIFO — first in applies It came out first. Raw materials and materials should be taken into storage in such a way as to guarantee full traceability and food safety. They should be inspected at the entrance and subjected to analyzes, the results of which guarantee safety and compliance with the specification. Internal transport should ensure adequate protection of the transported raw materials, semi-finished products and finished products against secondary and cross-contamination by microbiological, physical and chemical substances.

The so-called pharmaceutical GMP, or general requirements of good manufacturing practice, apply to manufacturers of medicinal products that are under the supervision of the Chief Pharmaceutical Inspector. In addition to, among other things, special requirements for the marketing of medicinal products, good manufacturing practices coincide with GMP and GHP in food production. Dietary supplements and foodstuffs for special nutritional purposes may not be manufactured in pharmaceutical GMP standard without the supervision of the State Sanitary Inspector.

Bibliografia

1. UsDirective of 25 August 2006 on food and nutrition safety

2. Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs

3. https://foodfakty.pl/systemy-ghp-i-gmp-cz-ii-w-praktyce

Hello and welcome!

I am a food technologist by education. I have 20 years of experience in the quality department in production plants. In the Europharma Alliance, I implemented the FSSC 22000 system, certified by TÜV Rheinland since 2016.
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