Procedures for applying for GMP Certificate for health protection foods

GMP certificate for health protection foods is a document certifying that a manufacturing facility meets Good Manufacturing Practice standards. Applying for this certificate requires the production facility to comply with strict procedures on quality control, hygiene and safety, and production management. This article will provide detailed information about the procedures, documents and application process for GMP Certificate for health protection foods.

What is health protection food?

Health protection foods are products that supplement the daily diet. The main purpose is to maintain, strengthen and improve the functions of the human body. These products also help reduce the risk of disease.

According to Clause 1, Article 3 of Decree 15/2018/ND-CP, health protection foods may contain one or more of the following substances:

• Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances
• Substances of natural origin from animals, minerals and plants in the form of extracts, isolations, concentrates and transformations
• Comprehensive sources of the above mentioned ingredients

Health protection foods are often processed in many forms such as capsules, tablets, tablets, granules, powder, liquid and other dosage forms. The product is dosed into small units for use.

The production of health-protective foods requires compliance with strict food safety regulations. This is to ensure the quality and safety of the product when it reaches consumers.

Conditions for ensuring food safety in the production of health protection foods

Producing health-protecting foods requires strict compliance with food safety conditions. These requirements are specifically stipulated in current legal documents.

According to Article 28 of Decree 15/2018/ND-CP, health food production facilities must meet the following conditions:

• Establish and maintain a quality management system to control the production and distribution process to ensure that all products manufactured by the facility meet quality standards according to published standards and are safe for users. Use until expiration date;
• Ensure adequate staff with GMP and food safety qualifications and related expertise
• Arrange the head of the production and quality control department to be an official, independent and experienced personnel
• The person in charge of the profession must have a university degree or higher and at least 3 years of working experience in the relevant specialized field;
• Factory systems, equipment and auxiliary utilities must be suitable, easy to clean and prevent pollution;
• Implement and store complete records and documents on production and quality control; distribution circulation to trace the history of every batch of products and records of all other activities performed at the facility
• All production operations must be carried out according to procedures and instructions. Apply inspection and supervision measures during the production process to prevent and avoid the risk of confusion, pollution, and cross-contamination. Record the results immediately when performing the operation or immediately after completing the production step in the records;
• Have a quality control department to ensure products are manufactured under appropriate conditions and processes and meet established standards; The necessary tests have been performed; Raw materials are not approved for export for use, products are not approved for sale without being assessed to meet the required quality; Products must be monitored for stability;
• In case of testing or production under contract, the contract recipient must have enough factories, equipment and personnel to meet the transferor’s requirements and comply with the regulations of the competent management agency on conditions. testing or producing health protection foods;
• There are procedures for resolving complaints, product recalls, and self-inspection activities; Follow the process and record and keep complete records for these activities.

In addition to the above conditions, health protection production facilities must meet general conditions for ensuring food safety clearly specified in Clause 1, Article 19, Clause 1, Article 20, Clause 1, Article 21 of the Law on Food Safety 2010.

Procedures for applying for GMP Certificate for health protection foods

Applying for a GMP Certificate for health protection foods is an important process. This process ensures the manufacturing facility meets safety and quality standards.

Application for GMP Certificate

According to Clause 1, Article 29 of Decree 15/2018/ND-CP, the application dossier for a GMP Certificate includes:

• Application for issuance of Certificate of establishment meeting food safety conditions meeting GMP requirements according to Form No. 12 Appendix I issued together with Decree 15/2018/ND-CP;
• Diagram of production areas and production lines (confirmed by the organization or individual);
• List of main equipment used at the facility (confirmed by the organization or individual);

Preparing complete and accurate documents is the first important step in the process of applying for a GMP Certificate. Documents need to be checked carefully before submitting to avoid errors that can delay the approval process.

Competent authority issues GMP certificate

The Ministry of Health is the agency responsible for issuing GMP Certificates for health protection foods. This is stipulated in Point a, Clause 2, Article 29 of Decree 15/2018/ND-CP.

Procedure for applying for GMP Certificate

The process of applying for a GMP Certificate is specifically specified in Clauses 1 and 2, Article 29 of Decree 15/2018/ND-CP. The sequence includes the following steps:

Step 1: Prepare documents:

Production facilities need to prepare all documents according to regulations. Careful preparation will help the approval process go quickly and smoothly.

Step 2: Submit application:

Applications can be submitted in one of three forms:

• Online public service system;
• Post office;
• Directly to the Ministry of Health;

Step 3: Appraisal of documents and actual assessment:

Within 15 working days of receiving complete and valid documents, the Ministry of Health will establish an appraisal team. The appraisal team consists of at least 5 people, including:

• At least 2 members have experience in GMP;
• 1 member has expertise in testing;

The appraisal team will conduct an actual assessment at the production facility. This process is intended to verify the accuracy of records and evaluate the facility’s ability to meet GMP requirements.

Step 4: Return appraisal results and issue certificate:

In case the requirements are met:

• The Ministry of Health will issue a Certificate of food safety eligibility that meets GMP requirements;
• Time to issue Certificate: no more than 30 working days from the date of receipt of complete and valid documents;

In case the requirements are not met:

• The appraisal team clearly notes the unsatisfactory content in the appraisal record;
• The facility needs to correct unsatisfactory points and send a written notice of corrective results to the Appraisal Team;
• Within 7 working days of receiving the written notice of remedial results, the appraisal team will review and submit to the Ministry of Health to issue a Certificate if satisfactory.

Duration of GMP certificate for health protection foods

The duration of the GMP Certificate for health protection foods is specifically stipulated in Clause 3, Article 29 of Decree 15/2018/ND-CP. This ensures the legality and validity of the certificate.

The certificate of establishment meeting food safety conditions meeting the requirements of Good Manufacturing Practices (GMP) for health protection foods is valid for 03 (three) years from the date of issue. This deadline allows the manufacturing facility enough time to implement and maintain GMP standards.

Before the expiration of 06 months, the facility is responsible for submitting the application for re-issuance of the Certificate. This ensures continuity in maintaining GMP standards and avoids interruptions in production operations.

Regulations on deadlines and re-issuance of certificates emphasize the importance of continuously maintaining GMP standards in the production of health-protective foods. This not only ensures product quality but also creates trust for consumers.

Consulting services and support procedures for applying for GMP Certificate for health protection foods

Long Phan provides consulting services and support procedures for applying for a GMP Certificate, which plays an important role in the registration process. We provide professional support to manufacturing facilities. Consulting services typically include:

• Assess the current status of the production facility;
• Consulting on improvements to meet certification conditions according to GMP standards;
• Support in preparing application documents for GMP certification;
• Support the facility during the process of the Ministry of Health appraising and evaluating the facility;
• Monitor document processing progress and provide information to customers.

Long Phan commits to accompanying businesses throughout the process, helping to save time, costs and improve efficiency. With extensive experience, we are confident in providing optimal solutions, ensuring businesses achieve GMP Certificate quickly and smoothly.

To ensure your rights and avoid legal risks, customers should consult experts and contact the hotline immediately 1900.63.63.89 for detailed advice on issues related to real estate trading floors, including procedures for suspending and restoring operations.