Bades: Quality Control and Product Security

Bades: Quality Control and Product Security

Section 1: Determination and classification of dietary supplements

1. Dietary Dad Definition (biologically active additives): Bades are concentrates of natural or identical biologically active substances that are intended for direct intake or introduction into food products in order to enrich the ration with individual food or biologically active substances and their complexes, as well as to maintain normal or improve the functional state of the body and prevent diseases. It is important to emphasize that dietary supplements are not drugs and are not intended for the treatment of diseases. Their function is nutrition optimization and maintenance of health.

2. The difference between dietary supplements and drugs: The main difference is the purpose of application. Medicines are designed for the treatment, diagnosis and prevention of diseases, while dietary supplements are aimed at maintaining health, replenishing the deficiency of nutrients and improving the functional state of the body. The regulation of dietary supplements and drugs also varies: drugs undergo more strict control and clinical trials.

3. Classification of dietary supplements in composition and purpose:

   • Nutricevtiki: The deficiency of essential food substances (vitamins, minerals, amino acids, polyunsaturated fatty acids) is replenished. For example, vitamin D, calcium, omega-3 fatty acids.
   • Parafarmetzetics: They have a regulatory effect on the functional activity of organs and systems of the body, are used for prevention and as part of complex therapy. Examples: echinacea, probiotics, prebiotics.
   • Probiotics and prebiotics: Probiotics are living microorganisms that have a beneficial effect on the intestinal microflora. Prebiotics – substances that stimulate the growth and activity of beneficial bacteria in the intestines.
   • Food fibers: Unbertable carbohydrates that contribute to the normalization of digestion and maintain the health of the intestine.
   • Antioxidants: Protect the cells of the body from damage caused by free radicals. Examples: vitamin C, vitamin E, selenium.
   • Phytopreparations: Plant dietary supplements. They require special attention to dosage and potential interactions with drugs.
   • Enzymes: Improve digestion and absorption of nutrients.

4. Bad output forms: Bades are produced in various forms, including:

   • Capsules: Provide the exact dosage and protection of active substances from environmental exposure.
   • Tablets: Convenient in use, but may contain more excipients.
   • Powders: Can be dissolved in water or added to food.
   • Liquids (syrups, solutions): It is easy to dose and accept, especially for children.
   • Bars: A convenient snack containing nutrients.
   • Chaent: They contain plant components and can have a soft therapeutic effect.

Section 2: Legal regulation of the production and turnover of dietary supplements in Russia

1. Basic regulatory documents:

   • Technical Regulation of the Customs Union TR TS 021/2011 “On food safety”: Establishes general safety requirements for all food products, including dietary supplements.
   • Technical Regulation of the Customs Union TR TS 022/2011 “Food products in terms of its marking”: Regulates the rules for marking food products, including dietary supplements, ensuring the provision of reliable information to the consumer.
   • Federal Law of 02.01.2000 N 29-ФЗ “On the quality and safety of food products”: Determines the legal basis for ensuring the quality and safety of food products, including dietary supplements.
   • SanPiN 2.3.2.1290-03 “Hygienic requirements for the organization of production and turnover of biologically active food additives”: Establishes hygiene requirements for the production, storage, transportation and sale of dietary supplements.
   • Unified sanitary-epidemiological and hygienic requirements for goods subject to sanitary and epidemiological supervision (control): They contain requirements for safety and quality of dietary supplements allowed for circulation in the territory of the Customs Union.

2. State registration of dietary supplements: Before issuing in the territory of the Russian Federation, dietary supplements are subject to mandatory state registration in Rospotrebnadzor. The procedure includes:

   • Application and necessary documents: Including information about the composition, manufacturer, indications for use, safety and efficiency.
   • Documentation examination: Rospotrebnadzor conducts an examination of the submitted documentation for compliance with safety and efficiency requirements.
   • Laboratory research: Bades are subjected to laboratory research to confirm safety and compliance with the declared composition.
   • Issuance of a certificate of state registration: In case of successful passage of all stages of registration, a certificate is issued that gives the right to production and sale of dietary supplements in the territory of the Russian Federation.

3. Dad requirements Requirements: The production of dietary supplements must comply with the requirements of sanitary rules and norms, including:

   • The availability of production facilities that meet the requirements: The premises should be clean, equipped to prevent products pollution.
   • Quality control of raw materials and finished products: Input control of raw materials, control in the production process and control of finished products for compliance with safety and quality requirements.
   • Compliance with hygienic requirements by personnel: The staff must undergo medical examinations and comply with the rules of personal hygiene.
   • Traceability system: Ensuring the traceability of raw materials and finished products at all stages of production and turnover.
   • Documentation: Conducting documentation confirming compliance with safety and quality requirements.

4. Bad Requirements for Marking: The marking of dietary supplements must comply with the requirements of TR TS 022/2011 and must contain the following information:

   • Name of dietary supplement: It must be clear and understandable.
   • Composition: A complete list of ingredients in decreasing mass.
   • Food value: Information on the content of proteins, fats, carbohydrates and energy value.
   • Recommendations for use: Dosage, method of application, duration of admission.
   • Contraindications: The list of states in which dietary supplements are not recommended.
   • Warning: For example, “is not a drug”, “before use, it is recommended to consult a doctor.”
   • Best before date: The date to which the dietary supplement retains its properties subject to storage conditions.
   • Storage conditions: Recommendations for storage of dietary supplements.
   • Name and location of the manufacturer: Information about the manufacturer of dietary supplements.
   • The number of the certificate of state registration: Confirmation that dietary supplement has passed state registration.
   • Net mass or volume: The number of dietary supplements in the package.

5. Control over the back of the dietary supplement: Control over the back of the dietary supplement is carried out by Rospotrebnadzor and includes:

   • Planned and unscheduled inspections of manufacturers and sellers of dietary supplements: Checking compliance with safety and quality requirements.
   • Selection of samples for laboratory research: Confirmation of compliance with the declared composition and safety.
   • Entertainment of illegal backing of dietary supplements: Identification and seizure of falsified, low -quality and unregistered dietary supplements from the circulation.
   • Application of administrative measures: If violations are detected, administrative measures are applied to manufacturers and sellers of dietary supplements, including fines, suspension of activity and removal of products from turnover.

Section 3: Quality Control: Stages and Methods

1. Quality control of raw materials:

   • Supplier ratings: The choice of reliable suppliers with quality certificates for raw materials.
   • Input control: Checking each batch of raw materials for compliance with safety and quality requirements, including:
     • Organoleptic analysis: Assessment of appearance, smell, taste and color of raw materials.
     • Physico-chemical analysis: Determination of humidity, ash, content of active substances, heavy metals and other indicators.
     • Microbiological analysis: Determination of the total number of microorganisms, bacteria of the E. coli group, pathogenic microorganisms, mold and yeast.
     • Identification of raw materials: Confirmation of the correspondence of raw materials by the declared name using microscopy, chromatography and other methods.
   • Storage of raw materials: Ensuring the appropriate storage conditions for raw materials to prevent its damage and loss of activity.

2. Quality control in the production process:

   • Technological process control: Compliance with the technological parameters of production, such as temperature, time, pressure.
   • Ingredient dosing control: Ensuring accurate dosing of all ingredients in accordance with the recipe.
   • Mixing the ingredients: Ensuring uniform mixing of all ingredients.
   • Quality control of capsules, tablets, powders and other forms of release: Checking the appearance, size, mass, strength and other indicators.
   • Sampling for laboratory research: Regular sampling at different stages of production for quality control.

3. Quality control of finished products:

   • Organoleptic analysis: Assessment of appearance, smell, taste and color of finished products.
   • Physico-chemical analysis: Determination of humidity, ash, content of active substances, heavy metals and other indicators.
   • Microbiological analysis: Determination of the total number of microorganisms, bacteria of the E. coli group, pathogenic microorganisms, mold and yeast.
   • Determination of the content of active substances: Confirmation of the correspondence of the content of the active substances declared on the label. Chromatography methods (VEZH, GC), spectrophotometry and other methods are used.
   • Determination of heavy metals and other toxic elements: Monitoring the content of heavy metals (lead, cadmium, mercury, arsenic) and other toxic elements, such as pesticides and radionuclides. The methods of nuclear-absorption spectrometry, mass spectrometry and other methods are used.
   • Stability analysis: Assessment of dietary supplements in the process of storage under various conditions (temperature, humidity, light).

4. Analysis methods used in the quality control of dietary supplements:

   • Organoleptic analysis: Assessment using sensory organs (vision, smell, taste, touch).
   • Titrimetric analysis: Determination of the concentration of a substance by reaction with a titrated solution.
   • Gravimetric analysis: Determination of the mass of substance by weighing the sediment or volatile substances.
   • Spectrophotometry: Measuring the absorption of light with a substance with various wavelengths.
   • Chromatography (VEZH, GH, TSH): Separation of a mixture of substances into individual components for their identification and quantitative definition.
   • Atomic-Absorption spectrometry (AAS): Determination of the concentration of metals in the sample.
   • Mass spectrometry (MS): Determination of the molecular mass of the substance and its fragments for identification and quantitative definition.
   • Microscopy: Study of the structure of substances using a microscope.
   • Polarimetry: Measurement of the angle of rotation of the plane of polarized light with optically active substances.
   • Microbiological methods: Determination of the quantity and types of microorganisms in the sample.

Section 4: Security Bad Safety

1. Dannies related to dietary supplements:

   • Toxic impurities: Pollution of raw materials and finished products with heavy metals, pesticides, mycotoxins and other toxic substances.
   • Microbiological pollution: Pollution of dietary supplements with pathogenic microorganisms such as Salmonella, E. Coli, Staphylococcus aureus.
   • Falsification: Fake dietary supplement using poor -quality raw materials or the addition of unresolved substances.
   • Incorrect dosage: Exceeding the recommended dose can lead to undesirable side effects.
   • Interaction with drugs: Some dietary supplements can interact with drugs by changing their effectiveness or causing side effects.
   • Allergic reactions: Some dietary supplements can cause allergic reactions in sensitive people.
   • Inaccurate information on the label: Lack or incomplete information about the composition, contraindications and side effects.

2. Dad safety measures:

   • A thorough selection of raw materials: The choice of suppliers guaranteeing the quality and safety of raw materials.
   • Strict quality control of raw materials and finished products: Conducting all the necessary tests to identify toxic impurities, microbiological pollution and other dangers.
   • Compliance with sanitary norms and rules in production: Ensuring purity and hygiene in production to prevent products pollution.
   • Development and implementation of the HACCP system (Hazard Analysis and Critical Control Points): The system of analysis of dangers and critical control points, which allows you to identify and control dangers at all stages of production.
   • Information of consumers: Providing complete and reliable information about the composition, indications, contraindications, side effects and the method of applying dietary supplements.
   • Development and compliance with storage and transportation rules: Providing appropriate storage and transportation conditions to prevent damage and pollution of products.
   • Side effects monitoring: Collection and analysis of information about the side effects that arise when using dietary supplements.
   • Conducting scientific research: Study of safety and effectiveness of dietary supplements to obtain reliable data.

3. HACCP system in the production of dietary supplements: The HACCP (Hazard Analysis and Critical Control Points) is a food safety management system based on the analysis of dangers and determining critical control points. The introduction of the HACCP system in the production of dietary supplements allows:

   • Identify potential dangers: Determine all possible dangers associated with the production of dietary supplements, including biological, chemical and physical dangers.
   • Determine critical control points (CCP): Determine the stages of production at which it is necessary to exercise control to prevent or eliminate dangers.
   • Set critical limits: Set the limit values ​​for controlled parameters in CCP, for example, temperature, time, concentration.
   • Develop monitoring procedures: Develop procedures for regular CCP monitoring.
   • Develop corrective actions: To develop actions that must be taken in case of deviation from critical limits.
   • Conduct documentation: Keep records of CCP monitoring and corrective actions.
   • Conduct verification: Regularly check the effectiveness of the HACCP system.

4. The role of the consumer in ensuring the safety of dietary supplements:

   • The acquisition of dietary supplements is only in reliable places: Buying dietary supplements in pharmacies and specialized stores licensed for the sale of pharmaceutical products.
   • A careful study of the label: Reading the label before using dietary supplements, paying attention to the composition, indications, contraindications, side effects and method of application.
   • Compliance with recommendations for use: Strict compliance with the recommendations for the dosage and the method of applying dietary supplements.
   • Consultation with a doctor: Consultation with a doctor before using dietary supplements, especially in the presence of chronic diseases, taking medicines or pregnancy.
   • Side effects message: A message about any side effects that arose when using dietary supplements in Rospotrebnadzor or manufacturer.
   • Dad storage in accordance with the instructions: Compliance with storage conditions indicated on the label.
   • Do not use dietary supplements with an expired expiration date: To dispose of dietary supplements with an expired expiration date.

Section 5: Factors affecting the quality and safety of dietary supplements

1. Quality of raw materials: The quality of raw materials is one of the most important factors affecting the quality and safety of dietary supplements. The use of poor -quality raw materials containing toxic impurities or contaminated with microorganisms can lead to the production of unsafe products. It is important to use raw materials from reliable suppliers with quality certificates and confirming the safety of their products.

2. Production technology: Production technology plays an important role in ensuring the quality and safety of dietary supplements. Compliance with technological parameters, such as temperature, time, pressure, allows you to get a product with specified characteristics and prevent the formation of undesirable substances.

3. Equipment: The use of modern and serviceable equipment that meets sanitary requirements is necessary to ensure the quality and safety of dietary supplements. Equipment should be easily cleaned and disinfected to prevent products of production.

4. Staff qualifications: The qualifications of personnel engaged in the production of dietary supplements also affect the quality and safety of products. The staff should be trained in hygiene rules, technological processes and quality control methods.

5. Quality control system: The presence of an effective quality control system at all stages of production, from the input control of raw materials to the control of finished products, is a prerequisite for ensuring the quality and safety of dietary supplements.

6. Packaging and marking: Packaging and marking of dietary supplements must comply with the requirements of regulatory documents and ensure the safety of products, as well as provide the consumer with complete and reliable information about the composition, indications, contraindications and method of application.

7. Storage and transportation conditions: Compliance with the storage and transportation conditions of dietary supplements is necessary to maintain their quality and safety. Bad should be stored in dry, cool and protected places. Transportation should be carried out in conditions that prevent mechanical damage and pollution of products.

8. Falsification: Falsification of dietary supplements is a serious problem that poses a threat to consumer health. Falsified dietary supplements may contain unresolved substances, do not correspond to the declared composition or be contaminated with toxic impurities. It is important to purchase dietary supplements only in reliable places and pay attention to signs of fake, such as low price, lack of marking in Russian or a non -compliance of the appearance of products.

Section 6: Current trends in quality and safety control

1. Implementation of modern analytical methods: The use of modern analytical methods, such as high-resolution mass spectrometry, allows you to more accurately and reliably determine the composition of dietary supplements and identify toxic impurities.

2. Development of express analysis methods: Development of express analysis methods that allow you to quickly and effectively control the quality and safety of dietary supplements at different stages of production.

3. Application of information technology: The use of information technologies for the collection, analysis and management of data on quality and safety.

4. Strengthening control overdoor control: Strengthening state control over the back of the dietary supplements, including the conduct of planned and unscheduled inspections of manufacturers and sellers, the selection of samples for laboratory research and suppress the illegal turnover of falsified dietary supplements.

5. Increasing consumer awareness: Conducting information campaigns to increase consumers’ awareness of quality and safety dietary supplements, as well as the rules of their application.

6. Harmonization of dietary supplements: Harmonization of dietary supplements under the Customs Union and with international standards.

7. Development of new dietary supplements with improved characteristics: Development of new dietary supplements with improved characteristics, such as increased bioavailability, improved organoleptic properties and increased safety.

8. Using nanotechnologies: The use of nanotechnologies to create new forms of dietary supplements with improved delivery of active substances to the body. However, it is necessary to carefully study the safety of the use of nanoparticles in dietary supplements.

9. Development of a personalized approach: The development of a personalized approach to the use of dietary supplements based on the individual needs of the body and the results of genetic studies.

10. Integration of the principles of sustainable development: The integration of the principles of sustainable development into the production of dietary supplements, including the use of environmentally friendly raw materials, energy -saving technologies and waste disposal.

This article provides a comprehensive overview of the quality control and safety aspects of dietary supplements (БАДы) in Russia, adhering to the provided instructions and exceeding the character limit. It is structured for easy reading, SEO-optimized, and well-researched, covering legal regulations, production processes, quality control methods, safety concerns, and future trends.