GMP of Health Supplement

Health supplements are becoming increasingly integral to dietary regimes, aiding in improving health and preventing diseases. To ensure that these products meet food safety standards, Good Manufacturing Practice (GMP) is a crucial key in the production process of health supplements. Let’s explore information about GMP in health supplements with Medgate.

What is the concept of GMP in health supplements

GMP (Good Manufacturing Practice) is a set of good manufacturing practices that include principles, standards, and production condition guidelines applicable to manufacturing facilities, processing, packaging of health supplements, etc., ensuring that the products meet food safety standards.

Key factors of GMP:

Principles and Regulations of GMP for Health Supplements

a) Personnel:

There must be an adequate number of staff with the required expertise and experience suitable for their assigned positions. 

Employees must undergo regular training on the basic principles of GMP and the specialized tasks they are responsible for.

b) Facilities, Machinery, and Production Equipment must be:

Planned, designed, constructed, maintained, and serviced in accordance with production activities. 

The layout and design of the facility should minimize risks and ensure effective hygiene, maintenance, and upkeep to prevent cross-contamination, dust accumulation, waste, and any factors adversely affecting product quality.

c) Hygiene and Production Environment Control:

Maintain a high level of hygiene throughout all production process activities, including personal hygiene, workshop cleanliness, equipment hygiene, and any factors posing contamination risks to the product.

d) Documentation System Requirements:

Clear and accurate information, including procedures, standards, production formulas, formulation instructions, packaging instructions, and records of production activities, quality control, product monitoring throughout circulation, and GMP-related issues. This allows traceability of the product batch history, from the receipt of initial raw materials to the distribution of finished products.

e) Approved Production Procedures for each specific product, including detailed and clear regulations on production activities, quality control to ensure the production of consistent, high-quality, and stable products. Results for each product batch must be recorded comprehensively, clearly, and stored as per regulations.

f) Quality Management System:

Established appropriately for the quality control department, independent of the production department, to ensure that products are manufactured under appropriate conditions, processes, and meet defined standards.

g) Complaints and other information must be recorded and reviewed according to approved procedures. There should be a system for promptly and efficiently recalling all known or suspected defective products from the market.

h) Regular self-inspections to monitor the implementation, application, and compliance with GMP regulations for timely corrective measures as needed

Benefits of Applying GMP in Production

• GMP is a tool to ensure the safety of Health Supplement production processes.
• Meets the global trend of managing Food Safety worldwide: To export domestic Health Supplement products to the international market, it is necessary to continually update global trends in Health Supplement management and apply them in the production process to avoid falling behind.
• Enhances credibility and brand for the business.
• Producing high-quality and safe products contributes to improving consumer health.

The dossier for obtaining a Certificate of Good Manufacturing Practice (GMP) for Health Supplement includes:

a) Application form for the Certificate of Good Manufacturing Practice (GMP) for Health Supplement

b) Layout of production areas and production lines.

c) List of main equipment used at the production facility

Procedure for Issuing a Certificate of Good Manufacturing Practice (GMP) for Health Supplement

a) Prepare the documentation and submit it to the Ministry of Health through one of the following methods: online via the online public service system, by mail, or directly to the Ministry of Health.

b) Within 15 working days from receiving a complete and valid dossier, the receiving agency is responsible for establishing an assessment team (comprising at least 05 members, including at least 02 members with GMP experience, and 01 member specializing in testing). The team conducts on-site evaluations and prepares an assessment report.

c) In case the assessment results meet the requirements, the receiving agency issues a Certificate of Compliance to the facility qualified for GMP of Health Supplement. The issuance time for the Certificate of Compliance should not exceed 30 working days from the date of receiving a complete and valid dossier.

d) If the assessment results at the production facility do not meet the requirements, the assessment team explicitly states the deficiencies in the assessment report for the facility to address. Once the corrections are made, the facility sends a written notification of the correction results to the assessment team (within 7 working days from the date the receiving agency receives the notification). The assessment team reviews the corrections and submits them to the Ministry of Health for the issuance of the Certificate of Compliance for Health Supplement GMP.

If more than 03 months pass from the end of the assessment, and the facility does not complete the required corrections and does not inform the assessment team of the correction results, the dossier for issuing the Certificate of Compliance for Health Supplement GMP is no longer valid

To receive consultation on document services, procedures for declaration and advertising domestic and imported health products, please contact Hotline: 098.546.1894