The well-established system of quality assurance in the West – Good Manufacturing Practice – applies to the production of pharmaceutical products, medical devices, food products, nutritional supplements and active ingredients.
The GMP concept stands on 3 pillars:
- selection of reproducible parameters
- determination of their quantitative characteristics
- description of measurement methods (devices)
More than 140 countries are currently participating in the GMP drug verification system
The GMP quality system includes an integrated approach:
- organization of the enterprise structure
- staff training
- selection and preparation of premises and equipment
- documentation management
- process technology management
- quality control of raw materials, materials, and end products
- work with complaints and reviews
- internal audit
This quality system concept combines meticulous workflow on the one hand and exceptional flexibility in terms of
introduction of the technological process – on the other.
On the territory of the Russian Federation, the GMP standard applies to the production of medicines (ГОСТ Р 55249-2009), and the “State Institute of Medicines and Good Practices” is responsible for checking for compliance with the standard.
SuperFood: This quality control system should be used in the production of specialty and functional foods, as these food categories are designed to meet the physiological needs of various population groups (including children, pregnant women and the elderly).
In the production of these foods, biologically active ingredients are widely used to achieve the required level of nutrients according to the recommendations for daily requirements – another reason to introduce GMP into food production.
In addition, these food products are subject to more stringent requirements than general food products, and an integrated approach is required to achieve the appropriate level of quality and safety.