Ensuring Food Safety in Health Supplement Production

Ensuring food safety in health supplement production are detailed to manage the activities of organizations trading in health support products. Manufacturing enterprises must establish an international standard quality management system to control cross-contamination risks. The appraisal process requires absolute compliance from infrastructure to personnel expertise. The following content guides the detailed registration process for Clients.

Requirements regarding facilities, equipment, and GMP management system

Conditions on Facilities, Equipment, and GMP Management System The production process is established on a one-way principle to thoroughly prevent contamination factors from the external environment. The Good Manufacturing Practice (GMP) management system plays a core role in maintaining stable product quality until the expiry date.

Based on Article 12 of Decree 46/2026/ND-CP (effective from April 16, 2026), technical requirements for facilities include:

• Location: Suitable location and area, safe distance from toxic/pollution sources.
• Water: Sufficient water meeting technical regulations for food production/business.
• Equipment: Sufficient equipment for handling raw materials, processing, packaging, preservation, and transport; sufficient washing/disinfection tools, antiseptics, and pest control equipment.
• Waste Treatment: Waste treatment system operated regularly according to environmental laws.
• Maintenance: Maintain food safety conditions; keep records of raw material origin and production processes.
• Personnel: Comply with health, knowledge, and practice regulations.
• Storage: Preservation areas must be spacious enough for separate storage, ensuring safety and hygiene. Prevent impacts of temperature, humidity, pests, dirt, and strange odors; ensure sufficient light and ventilation.

General Conditions on Equipment, GMP Management System, and Record Keeping:

• Establish and maintain a quality management system according to GMP principles for health supplements.
• Factory systems and equipment must be designed/installed for suitable use, following the one-way principle, easy to clean, preventing confusion and cross-contamination.
• Keep full records of production, quality control, and distribution to trace product history.
• Production operations must follow procedures/instructions. Apply inspection/supervision measures to prevent errors/contamination. Record results immediately.
• Contract Manufacturing: Contractors must have sufficient facilities/personnel meeting requirements and complying with regulations.
• Quality Control: Have a QC department to ensure products meet established standards; materials/products are not released until approved; monitor stability.
• Procedures: Have procedures for handling complaints, product recalls, and self-inspection; keep full records.

>>> See more: Food Production and Processing Licensing Consulting Service

Standards regarding personnel, training, and professional qualifications for those in charge

Human resources are the decisive factor in maintaining food safety conditions. Key management positions must have suitable professional degrees and practical experience in the medical/pharmaceutical field.

According to Article 12 of Decree 46/2026/ND-CP:

• Staff: Sufficient staff with suitable professional qualifications and trained in GMP and food safety.
• Person in Charge of Expertise: Must have a university degree or higher in Medicine, Pharmacy, Nutrition, Food Safety, or Food Technology. Must have at least 03 years of practical experience in relevant fields.
• Heads of Production and Quality Control: Must be official, full-time personnel, independent of each other to ensure objectivity.
• Training: All staff directly involved in production must be trained in GMP, personal hygiene, and equipment operation. Training records are mandatory for inspection.
• Health: Periodic health checks; no infectious diseases; strict compliance with protective clothing regulations.

Regulations on the management of GMP Certificates for facilities

The GMP Certificate is a mandatory administrative procedure. It has a specific validity period and requires periodic reporting.

Based on Article 13 of Decree 46/2026/ND-CP, the licensing and management process includes:

1. Submission of Dossier:

• Application for GMP Certificate Form No. 12 Appendix I Decree 46/2026/ND-CP.
• Master plan and detailed layout of production areas, lines, storage, and testing areas (confirmed by the organization).
• List of main equipment (confirmed by the organization).

2. Actual Appraisal:

• Dossier Review: If modification is needed, notify within 05 working days. If not supplemented within 30 days, the dossier becomes invalid.
• Appraisal Team: Established within 15 days of receiving a valid dossier. The team has 05-06 members (at least 02 GMP experts, 01 testing expert).
• Approval: If eligible, grant the Certificate within 30 days of receiving a valid dossier.
• Correction: If correction is needed, the facility must remedy and report. Within 07 working days of receiving the report, the team reviews for submission to the Ministry of Health. If not completed within 03 months, the dossier becomes invalid.
• Fail: If ineligible, notify within 15 working days; the facility cannot operate until certified.

Validity and Re-issuance: Valid for 03 years. Apply for re-issuance at least 06 months before expiration. Reporting: Periodic report every 12 months. Submit to the Food Safety Authority within 15 days from the end of the reporting period. Notify changes in name/legal representative immediately.

>>> See more: Domestic Medical Nutrition Product Registration

Long Phan Consulting Company provides consulting services for obtaining GMP certificates

Long Phan Consulting Company supports clients in optimizing the process of meeting food safety conditions in health supplement production. We provide comprehensive technical solutions from factory design to building a standard GMP documentation system. We structure our support into the following key areas:

• Providing advice on the conditions and standards applicable to each field (pharmaceuticals, cosmetics, health supplements, medical devices, etc.), ensuring food safety in health supplement production.
• Review and assess the current state of facilities, production lines, and quality management systems.
• Consulting services for developing and refining GMP documentation systems (SOPs, manufacturing processes, quality control procedures, batch records, personnel records, etc.).
• Instructions for preparing and completing the application for GMP certification: Drafting quality management documentation, standard operating procedures (SOPs), and production record forms. These documents are specifically designed to suit each organization’s actual production line.
• Personnel training: We organize training courses on Good Manufacturing Practice (GMP) for managers and employees. We assist in reviewing the qualifications and certifications of those in charge of specific areas to ensure compliance with legal regulations.
• Our representative handles the procedures: We submit the application on your behalf, monitor the progress, and receive the inspection team at your facility. We assist in resolving any technical errors that arise in the inspection report to ensure you receive your official certificate as soon as possible.

>>> See more: Procedures for applying for GMP Certificate for health protection foods

Frequently Asked Questions about ensuring food safety in health supplement production

Below are questions related to the ensuring food safety in health supplement production:

If the audit results require corrective action, how much time does the business have? 

Within a maximum period of 3 months from the date of completion of the assessment, if you do not complete the corrective actions and notify the assessment team of the results, your application for a license will no longer be legally valid. After this period, the organization must submit a new application from scratch for re-evaluation by the competent authority according to the prescribed procedure.

(Legal basis: Point d, Clause 2, Article 13 of Decree 46/2026/ND-CP)

Is it permissible to outsource the production of health supplements to other facilities under contract? 

Yes. However, the contracted processing unit must possess a factory system, equipment, and personnel that fully meet the corresponding GMP technical standards. The contractor is obligated to strictly comply with regulations on production conditions and is subject to direct supervision by the competent state management agency.

(Legal basis: Point g, Clause 1, Article 12 of Decree 46/2026/ND-CP)

How long does the on-site inspection take from the time all valid documents are received? 

Within 15 days of receiving a complete and valid application, the receiving agency is responsible for forming an assessment team consisting of 5 to 6 experts to conduct an on-site evaluation. The assessment team must include at least 2 members with experience in Good Manufacturing Practice (GMP) and 1 member with in-depth knowledge of product testing procedures.

(Legal basis: Point c, Clause 2, Article 13 of Decree 46/2026/ND-CP)

What detailed technical documents are included in the application for a GMP certificate? 

The application package includes the application form (Form No. 12), a list of key equipment, and important technical drawings of the organization. Specifically, you need to provide a general layout and detailed diagrams of the production areas, operating lines, storage systems, and testing laboratories, officially certified by the organization’s representative.

(Legal basis: Clause 1, Article 13 of Decree 46/2026/ND-CP)

When are businesses required to submit periodic reports to the Food Safety Administration?

The manufacturing organization is obligated to prepare periodic reports every 12 months from the date of issuance of the GMP Certificate. These reports must be submitted to the Ministry of Health (Food Safety Department) within 15 days from the last day of the reporting period for monitoring and post-inspection purposes as required.

(Legal basis: Clause 6, Article 13 of Decree 46/2026/ND-CP)

If the name of the legal representative changes, is it necessary to apply for a new certificate? 

You are not required to go through the re-issuance procedure if there are no changes to the approved location and scope of operation in the current Certificate. However, the organization is responsible for immediately notifying the issuing authority of any changes to the legal representative or the name of the facility in order to update the management data.

(Legal basis: Clause 4, Article 13 of Decree 46/2026/ND-CP)

Conclusion

Correctly implementing conditions for ensuring food safety in health supplement production is the foundation for enterprises to affirm their reputation. Clients should pay special attention to the continuity of the GMP system and license validity.

For in-depth support on certification procedures and factory technical advice, please contact Long Phan Consulting Company via Hotline 1900636389 immediately.