What is Health Protection Food? Conditions to Ensure Food Safety in the Production of Health Protection Food?
Application dossier for the Certificate of Good Manufacturing Practice (GMP) for Health Supplements
According to Clause 1, Article 29 of Decree No. 15/2018/ND-CP, the application dossier for the Certificate of Good Manufacturing Practice (GMP) for health supplements includes:
- An application form for the Certificate of Good Manufacturing Practice (GMP) for health supplements as per Form No. 12, Appendix I, issued with Decree No. 15/2018/ND-CP;
- A diagram of the production areas and production lines (with confirmation from the organization or individual);
- A list of the main equipment used at the facility (with confirmation from the organization or individual).
What are health supplements?
Based on Article 3 of Decree No. 15/2018/ND-CP, the regulation is as follows:
Terminology Explanation
In this Decree, the following terms are understood as follows:
1. Health supplements (Health Supplements, Dietary Supplements) are products used to add to daily dietary policies in order to maintain, enhance, and improve bodily functions, and reduce disease risks. Health supplements contain one or several of the following substances or a mixture of these substances:
a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances;
b) Substances of natural origin, including animals, minerals, and plants in the form of extracts, isolates, concentrates, and conversions;
c) Synthetic sources of the components mentioned above in points a and b.
Health supplements are presented in processed forms such as capsules, pills, tablets, granules, powders, liquids, and other dosage forms and are dosed into small unit dosages.
- Medical nutritional food, also known as food for special medical purposes (Food for Special Medical Purposes, Medical Food), is food that can be ingested orally or through a tube, suggested to adjust the diet of patients, and must be used under the supervision of medical personnel.
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Health supplements are products used to add to daily dietary policies to maintain, enhance, and improve bodily functions, and reduce disease risks.
Health supplements contain one or several of the following substances or a mixture of these substances:
- Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, and other bioactive substances
- Substances of natural origin, including animals, minerals, and plants in the form of extracts, isolates, concentrates, and conversions
- Synthetic sources of the above components
Health supplements are presented in processed forms such as capsules, pills, tablets, granules, powders, liquids, and other dosage forms, dosed into small unit dosages.
What are health supplements? Conditions to ensure food safety in health supplement production? (Image from the Internet)
Conditions to ensure food safety in health supplement production
According to Article 28 of Decree No. 15/2018/ND-CP, health supplement production facilities must meet the general conditions for ensuring food safety stipulated in Clause 1, Article 19; Clause 1, Article 20; Clause 1, Article 21 of the Law on Food Safety 2010 and the following requirements:
- Establish and maintain a quality management system to control the production and distribution processes to ensure that all products manufactured by the facility meet the declared standards and are safe for users until the expiration date;
- Have adequate personnel with appropriate professional qualifications for the assigned job positions and provide basic training on GMP, food safety, and relevant professional knowledge.
+ The head of the production department and the head of the quality control department must be official, full-time employees of the facility and operate independently of each other.
+ The person in charge of the facility must have a university degree or higher in one of the following fields: Medicine, Pharmacy, Nutrition, Food Safety, Food Technology, and must have at least 3 years of experience in the related specialized field;
- The system of workshops, equipment, and auxiliary facilities must be designed, built, and installed in accordance with the purpose of use, following a one-way principle, being easy to clean, preventing and minimizing the risk of confusion, accumulation of dirt, contamination and factors adversely affecting the product, and maintaining daily hygiene activities;
- Implement and store full records and documentation on production, quality control, distribution to trace the history of every batch of products and record all other activities performed at the facility;
- All production operations must be carried out according to procedures and guidelines. Apply inspection and monitoring measures during the production process to prevent confusion, contamination, cross-contamination. Record results immediately upon performing the operation or immediately after completing the production stage in the records;
- Have a quality control department to ensure that the product is manufactured under suitable conditions, processes, and meets established standards; necessary tests have been conducted; materials are not approved for use, products are not approved for sale until quality requirements are met; products must be monitored for stability;
- In cases of contract testing or production, the contracted party must have adequate facilities, equipment, and personnel to meet the requirements of the contracting party and comply with regulatory authority requirements regarding conditions for testing or producing health supplements;
- Have procedures for handling complaints, product recalls, internal inspections; conduct according to the procedures and fully record and store documentation for these activities.
