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The production of health supplements is a process that requires strict adherence to regulations on safety and quality to produce products that meet standards and contribute to improving the health and quality of life of consumers. Adhering to legal regulations on the production of health supplements helps businesses enhance their brand reputation and create trust in consumers regarding a quality product. The insights shared by Medgate below will help you understand more about the conditions for producing health supplements.
Legal basis/legal documents
– Decree No. 15/2018/NĐ-CP issued on February 2, 2018: Provides detailed regulations for implementing certain provisions of the Food Safety Law.
– Circular No. 18/2019/TT-BYT issued on July 17, 2019: Guides the implementation of Good Manufacturing Practices (GMP) in the production and business of health supplements
Health supplement production facilities must meet the following conditions:
a) Establish and maintain a Quality Management System (QMS):
Purpose: To control the production process and distribution to ensure that all health supplements produced meet the quality standards declared by the facility and remain safe for consumers until the expiration date.
b) Adequate and qualified personnel:
– Employees should be trained in basic knowledge of Good Manufacturing Practices (GMP), food safety, and other relevant professional knowledge.
– Heads of production and quality control departments must be full-time employees working independently.
– The person in charge of the production facility must have at least a university degree and a minimum of 3 years of experience in one of the following fields: Medicine, Pharmacy, Nutrition, Food Safety, Food Technology.
c) Factory systems, equipment and auxiliary utilities
– Suitable for the intended purpose.
– Designed according to a one-way flow, easy to clean, prevent contamination, minimize the risk of errors, avoid the accumulation of dust, pollution, and other factors adversely affecting the product.
d) Documentation and records on production, quality control, and distribution must be stored adequately:
Purpose: To trace the history of each product batch and maintain records of all other activities carried out at the facility.
e) Clear procedures, instructions for all operations + Inspection and monitoring measures during production:
Purpose: To prevent the risk of confusion, pollution, and cross-contamination. Record results immediately after performing operations or upon completion of production stages in documentation.
f) Quality control department to:
– Ensure products are produced under appropriate conditions and processes, meeting established standards.
– Perform necessary tests.
– Raw materials are not approved for use, and products are not approved for sale until they have been assessed for quality compliance.
– Monitor the stability of the produced products.
g) In case of outsourcing product processing:
The contracting party must have adequate factory system, equipment, and personnel to meet the requirements of the contracting party and comply with the regulations of the competent authority regarding testing conditions or the production of health supplements
h) Have procedures and implement the specified process for handling complaints, product recalls, and self-inspection activities
Important notes on the conditions for producing health supplement
Starting from July 1, 2019, health supplement production facilities must adhere to Good Manufacturing Practices (GMP) for health supplements as per the guidelines provided by the Ministry of Health.
The application for a Certificate of Eligibility for Health Supplement Production meeting GMP requirements includes:
a) A request form for the Certificate of Eligibility for Health Supplement Production meeting GMP requirements, using Form No. 12 in the Appendix I issued with this Decree.
b) Diagrams of production areas and production lines (with confirmation from organizations or individuals implementing production).
c) A list of the main equipment used at the facility (with confirmation from organizations or individuals implementing production).
For manufacturers of medicinal herbs and traditional medicines that have been granted a Certificate of Good Manufacturing Practices (GMP) for drugs and raw materials by the Drug Administration – Ministry of Health, the Traditional Medicine Management Department – Ministry of Health, the certification remains valid according to the regulations of the law on drugs. This applies to health supplements produced in corresponding formulations to those already certified. In such cases, there is no need to go through the procedure of obtaining a Certificate of Eligibility for Health Supplement meeting GMP requirements for health supplement
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