GMP HS Standard

Health-protective foods (TPBVSK) are products used for the purpose of supporting treatment, improving recovery, promoting human health. TPBVSK is a product under the management of the Ministry of Health in the functional food group (as defined in the Food Safety Law 2010).

Enterprises wishing to produce TPBVSK must be granted a certificate of food safety eligibility by the Ministry of Health. Previously, the conditions of facilities for the production of TPBVSK were relatively general, as shown in Chapter IV of the Food Safety Law like many other foods. These conditions are then specified in more specific and detailed in Decree No. 67/2016/ND-CP exclusively for food groups under the management of the Ministry of Health.

Recognizing the risks to the safety and quality of TPBVSK, the regulations on the conditions of facilities for the production of TPBVSK are not really strict. Meanwhile, the dosage forms of TPBVSK are completely similar to pharmaceutical products. Based on the good practice guidelines (GMP) for pharmaceuticals, the Ministry of Health has drafted and issued the “Good Manufacturing Practice Guidelines (GMP) in the production and trading of health-protective foods” (Circular 18/2019/TT-BYT) referred to as “GMP-HS standard”.

Certificate of establishment meeting good manufacturing practice (GMP) Health Food

The GMP-HS standard is good manufacturing practice. This standard applies to health foods (HS stands for health supplement). This is a guidance system to ensure TPBVSK products are produced in a uniform and according to established quality requirements.

The introduction of the “GMP-HS Standard” really made a big change. This requires enterprises to invest, improve facilities, build quality management systems, control each stage of tpbvsk production activities. From there, we create increasingly safe and quality products.

In order to meet GMP-HS standards, TPBVSK manufacturers must meet the principles and standards of good practice set out in Circular 18/2019/TT-BYT. In this article, GMP Groups asks permission to make the most general and general requirements.

Just like GMP for pharmaceuticals, the requirement to meet the GMP-HS standard consists of two parts: Hardware and Software. In which hardware is factory system, machinery and equipment, auxiliary system. Software is a document records process system.

When the business builds well in both hardware and software, combined with a trained team of personnel, your business has met the GMP-HS standard.

Cleanrooms for health food production

a) Applying GMP-HS standards is a condition for being allowed to produce safe and healthy foods.

State agencies conduct inspections of TPBVSK manufacturing companies based on GMP-HS guidelines. Upon meeting the requirements, the enterprise is newly granted a certificate of food safety eligibility facility meeting the requirements of good production practice (GMP) tpbvsk..

b) Applying GMP-HS standards is a condition for companies to maintain tpbvsk production activities.

The inspection not only takes place at the beginning when issuing “licenses” but is also carried out unexpectedly or periodically by state management agencies. If a business does not comply with the GMP-HS standard, based on the level of non-compliance, the production of that business may be stopped.

a) Apply GMP-HS standards to help enterprises create safe, high-quality tpbvsk

GMP-HS standards provide guidelines on organization, management – review – quality inspection system, requirements on factories, equipment, people, document records, production processes … All of these factors are intended to ensure that systematic, compliant, controlled production activities are closely monitored. The product will be quality assured at all stages, not simply check the final quality. 

b) Applying GMP-HS standards helps to raise businesses, increase trust for consumers and partners, thereby increasing revenue and profit.

Because of its legality, the GMP-HS standard is indispensable when a business demonstrates its capacity to fulfill processing orders from partners, as well as distribute products to dealers, sales units.

c) Applying GMP-HS standards increases the professionalism, discipline of the organization, exercises the carefulness, compliance of people, creating its own characteristics: GMP culture, GMP people.

With the requirements and guidelines, GMP-HS standards help businesses build a quality management system, a strict, strong process system, constantly improving and improving. There, people are carefully trained, disciplined, highly compliant, thereby creating a professional working environment with the characteristics of GMP.

d) GMP HS helps to affirm quality and build trust and brand in the hearts of consumers.

It is the basis for bringing Vietnamese brand health protection food to the world. At that time, consumers not only can use safe and quality products, but also increase awareness of basic hygiene, add trust in Vietnamese goods and improve the quality of life. Affirming quality and building trust and brand in the hearts of consumers.

e) Applying GMP HS standards is to meet the trend of ATTP management in the world

In order to enter the international market, TPBVSK manufacturers must always update new trends. The current global attp trend is as follows: 

Switch from product testing to process control: just like prenuptial and prenuptial health checks, healthy parents give birth to healthy children who do not have genetic diseases. If the product wants to be good, it must be standardized from the selection of raw materials, production …

– Switch from checking product quality indicators to controlling factors that affect quality in the production process.

– Switch from passive removal of defective products to proactive and comprehensive prevention of the risks of error

Move from independent testing to mutual recognition.

GMP-HS cleanroom appraisal designed and constructed by GMP Groups

GMP Groups, with its many years of staffing in pharmaceutical companies and TPBVSK, understand the nature of GMP-HS requirements. We understand the difficult obstacles of customers in production activities in compliance with GMP-HS principles and standards. Therefore, GMP Groups has created a comprehensive solution to help customers meet and maintain GMP-HS standards including:

6.1. GMP-HS cleanroom design and construction consultancy service: serving during the construction of the factory.

GMP Groups ensures the proper design of GMP-HS principle standards, convenient for customers in the production process. Construction services ensure accurate, on schedule, regular updates for investors through the visual imaging system.

6.2. Consulting services, supplying production machinery and equipment

Ensure consultation and provide customers with a full equipment system of each line. It is accompanied by a system of assessment and appraisal records that fully meet the requirements of GMP-HS.

6.3. Services to set up document records system, standard operation process

GMP Groups provides customers with the most reasonable and complete set of documents and processes. Customers have a good understanding of the document record system, standard operation process in compliance with principles and good practice guidelines.

6.4. Training services and guidance on operation of quality management system

GMP Groups will help customers train human resources to understand the nature of GMP in general and GMP-HS in particular. We guide our customers’ human resources team to operate and maintain a quality management system that meets the requirements of GMP-HS standards.

GMP Groups is committed to a lifetime commitment to accompanying customers, ensuring to help customers obtain certificates meeting GMP-HS standards. We support customers to overcome the backlog after each inspection. Maintenance of the factory during production activities, renovation of the factory according to the requirements of customers.

In the process of producing health food, GMP Groups also provides customers with consulting services for preparation technology, helping customers get new, quality and effective products.

Contact consultants applying GMP-HS standards in package at: 

GMP Groups Joint Stock Company

Head office: No 273 Hoa Ban, Ecoriver Eco-Investor, Hai Tan Ward, Hai Duong City, Hai Duong Province

Hotline: 0945.255.457 – Email: info@gmpgroups.com.vn – Web: gmpgroups.com.vn