The application of Good Manufacturing Practices (GMP) in the field of supplements is essential to ensure the highest levels of product quality and safety.
Food supplements have become the subject of increasing attention from the scientific and economic world, given their ever-increasing consumption in all European countries and in Italy.
Various interests revolve around the food supplements business, from the public administration, to health workers, from the scientific community to consumers.
The Code of Good Manufacturing issued by the FDA (Food and Drug Administration, Agency for Food and Medicines) – a US government body that deals with the regulation of food and pharmaceutical products – is a point of reference for European organizations.
The FDA code in fact represents a qualified and recognized guide to ensure the quality and safety of food supplements during the entire production cycle of the product and its preservation.
The GMP guidelines follow some key points of the FDA model including the requirements for integrator manufacturers to be recognized as certified subjects.
To date, the application of GMPs is still optional and not binding on the sale and export of supplements, however the growing attention to quality products and processes pushes more and more companies to adopt good practices and to request certification from the relevant bodies.
GMP certification requirements for food supplements
The main requirements of GMP regarding food supplements concern three types of themes:
1) Work organization area:
Human Resources – Factories and production land – Equipment, instruments and tools – Production control systems and production processes
2) Manufacturing area:
Production and process control systems – Quality – Control of raw materials and components – packaging materials and labels – Control of laboratory operations, packaging and labeling
3) Conservation and distribution area
Warehouse – Logistics – Returns – Complaints related to the product
In addition to certifications, periodic inspection services are offered by certification companies.
The Inspection is carried out at the offices and production premises of the integrator manufacturer and has the purpose of verifying the application of the procedures that the Organization has prepared to ensure that the production, packaging and storage processes of the integrators are carried out in accordance with Good Manufacturing Practices (GMP).
The elements that characterize the Good Manufacturing Code concern:
– staff in terms of training and hygiene and health;
– management, cleaning and maintenance of premises and equipment;
– the control system to be implemented at all stages of production, packaging, labeling and storage;
– carrying out quality controls;
– preparation and control of Production Batch Records;
– handling of non-specific items, non-compliant products, returns and complaints;
– the “change control”;
– the documentation (procedures / operating instructions / registration) necessary for the correct management of operational processes.
The inspection activity is generally carried out on an annual basis and is carried out using the Good Manufacturing Code issued by the FDA (Food and Drug Administration) as a reference model.
At the end of each inspection, the results of the inspection and the application status of the GMP requirements are made available to the Customer
The inspection on the application of the GMP requirements can be carried out at the same time as other checks already planned and can be preceded by a preliminary inspection.