"Get GMP
Get what you want"

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Investing in Health Supplement Manufacturing Facility
05 things to be considered!

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Manufacture of Health Supplements is a conditional business line.

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According to the Decree No.15/2018/ND-CP, effective from 01 July 2019, Health supplements manufacturing facilities are required to apply Good manufacturing practices for health supplements (HS GMP) in accordance with the guideline of Ministry of Health.

On 17 July 2019, the Ministry of Health issued Circular No.18/2019/TT-BYT provide guideline on Good manufacturing practices (GMP) that applied to the production and trade of heath supplements.

A health supplement product can be legally announced and circulated only if it was produced at a facility with Certificate of Good manufacturing practices in Health Supplement (referred to as “HS GMP”)

Compliance with HS GMP guideline brings many benefits for enterprises, in which the biggest benefit is to affirm the product quality and build branch trust in customers awareness.

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•  An effective tool to ensure food safety (ATTP)
•  Ability to proactively prevent food contamination during the production
•  Screening and removing unqualified health supplement manufacturing facilities
•  Continuously keep update food safety issues & trends to never be outdated.
•  Be the legal prerequisites for enterprises to export products to foreign countries.

Why HS GMP important?

What is Health Supplements?

1. Health Supplement (Food Supplement, Dietary Supplement) is the product that is used to supplement a diet to maintain, support or improve the healthy functions of the human body, reduce the risk of disease. A health supplement must contain one or more, or a combination of the following ingredients:
a) Vitamins, minerals, amino acids, fatty acids, enzyme, probiotic and other bio-active subtances.
b) Substances derived from natural sources, including animal, mineral and botanical materials in the forms of extracts, isolates, concentrates and transforms.
c) Synthetic sources of the ingredients mentioned at the above points.
2. A health supplement must be presented in a dosage forms such as capsules, pills, tablets, granules, powder, liquids and other dosage forms, and must be administered in small unit doses (to use).

Ensuring to produce the safe and qualified health supplement product.

Adapting to food safety control trends in home and aboard.

Adapting with the requirements of international economic integration and demands of market.

Screening and removing unqualified products, brings benefits to consumers

Controlling the factors that affect product quality.

Potential benefits when applied
 
HS GMP regulations

Sample Projects - 3D Models
Health Supplement Manufacturing Facility

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  • Minimum project scale: 1800m2 
  • Minimum project requirement: 600m2 ( one product line) & 800m2 ( two product lines) 
  • HS GMP Authority:  Department of Food Safety Hegiene  - Ministry of Health   

PROCEDURE & SERVICE PACKAGES

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G01. Preliminary-Overall Consultancy       

G02. Technology and equipments consultation

G03. Detailed Construction Drawings Design

G04. Construction Management and Supervision 

G06. Drafting registration dossier & Defense (VFA)

G05. HS GMP Training

  • Send qualified personnel to preside, or collaborate with investor's personnel in order to Manage and Supervise the project construction.
  • Manage and Supervise the construction contractor to ensure: Quality, Progress, Cost, Construction Safety in accordance with Design and Contract.
  • Creating IQ, OQ, PQ documents for all equipments and system in project, in order to complete the necessary dossier in compliance with  HS GMP requirements
  • GMPc's Training service is Creative, Professional, especially Effective, focus on Practices guidance combining with Theoretical training (Training on job)
  • Directly Guide to Draft and Finalize the CGMP ASEAN registration dossier in compliance with DAV requirements.
  • Ensuring your workforce will confidently answer and defense to the HS GMP inspection team, as well as be equiped the HS GMP knowledge and practical skills to take control the operation of facility.
  • Gain the sympathy the authorities when receiving and evaluating
  • Saving time because the dossiers are responsive the start
  • Equip the necessary knowledge for the workforce to take control the presentation to GMP inspection team.
  • Confident presenting with definite report.
  • Can the existing facility be renovated to meet the requirements? In case of investor have to rent/buy land, what is the minimum area needed?
  • Total investment amount? Project implementation time?
  • Site Master Planning, Site layout design for all areas?
  • Master Plan, with clear description of works?
  • Make responsibility to the results of the project? 
  • Selecting the optimal technology/ manufacturing process
  • Selecting appropriate machinery and equipments for chosen manufacturing process, ensuring to optimize the investment operating expenses.
  • GMPc always provides optimal solutions and necessary informations to support our customers in making decisions on choosing the most appropriate technology, equipments and suppliers.
  • Detailed design (renovation/new construction) for the facility and auxiliary items.
  • Detailed MEP system design: HVAC system, Electricity system, Extra-low voltage system, Panel, Floor Paint, Shelves, BMS, ...
  • Detailed Budgeting (Equipments/Supplies, Quantity, Unit Price, Total Cost)
  • Ensuring the Design dossier and Budgeting are clear and objective, it can be used as STANDARD for competitive bidding between contractors.

About Us

Established since May 25, 2021 GMPc proud to have been the pioneer consultant in providing a comprehensive and turnkey consulting model for GMP-certified facility projects.
Having competent manager, GMP experts and professional team of staff including pharmacists, engineers, chemists,..with several years experiences on GMP practices at large-scales factories, we have always been dedicating ourselves into each commissioned project while adhering to the core value of Get GMP – Get what you want!
GMPc has been trusted by most nationwide investors with over 190 GMP-certified facility projects, which equals to more than 80% market share in Vietnam from 2011 to 2021. Because of customer's faith, we ensure to be always do our best to create and contribute the consulting solutions that Simplification - Cost Optimization - Guaranteed Certification on the basis of understanding the needs and differentiation strategy of each customer.

+10 

years
experience

Branch
Hanoi & HCMC

Projects
GMP facility

+190

See more: GMPc capacity profile

Website: www.gmp.com.vn

Why choose GMPc Vietnam?

3 main reasons that influence 80% of Vietnam GMP-project investors choosing GMPc as consultant!

  • Only one consultant for whole project
  • We get GMP - We get what you want.
  • Detailed implementation plan, indicating all possible options so investor can make the final decision.
  • Single choice to resolve all arising problems

2. Turnkey consulting solution

  • In compliance with HS GMP regulations; 
  • Meet the Authorities' requirements; 
  • Optimization of investment and operation cost; 
  • Controlled progress; 
  • Certification- success rate of 100% 

3. Taking responsibility

  • The choice of all leading brands: Nutifood, ADC, Mediplantex, Hai Duong Central College of Pharmacy ...
  • Success rate of 100%.
  • Satisfied all investors.
  • Highly praised by authorities.

 1.  Affirmed Reputation

NUTIFOOD - Food Manufacturing Facility

Address: E3-E4 My Phuoc IP, Ben Cat, Binh Duong

ADC - Health Supplement Facility

TYPICAL PROJECTS

Address: Tan An, Ninh Kieu, Can Tho

See more: List of project consulted by GMPc Vietnam (2011-2021)

NGOC DUY TEA - Atiso Facility

Address: Phan Chu Trinh, District 9, Da Lat, Lam Dong

Health Supplement Facility - Hai Duong Central College of pharmacy

Address: 324 Nguyen Luong Bang, Hai Duong

CUSTOMER'S REVIEW

" NIMM is a direct unit under Vietnam Ministry of Health, with the mission of scientific research and promoting comprehensive technological developments of medicinal materials, as well as consulting the Ministry of Health on the methods of development medicinal materials, modernizing oriental (traditional) medicine, pharmaceutical production and business, giving training to cadres in this field.
NIMM choose GMPc as our consultant in facility evaluation, GMP training and drafting GMP registration dossier.
I highly appriciate the capacity, knowledge as well as GMP/GLP/GSP practices in medicinal materials production of GMPc Vietnam."


Associate Professor - PhD. Nguyen Minh Khoi
Head of NIMM Institute

 100% GMPc's customer are satisfied with our services!

"Hai duong central college of pharmacy is public training institute and also research center for application of science and technology into the production, business and services on pharmacy, cosmetic, health supplements.
Thanks to GMPc's consulting service on facility infrastructure and  GMP/GLP/GSP training, we has successfully accomplished the pharmaceutical business and research center project with GMP certification approved by VFA.
With the current mindset and drive, GMPc will definitely reach higher accomplishments.

PhD. Nguyen Ba Kien
Vice principal - Hai Duong central college of pharmacy

Frequently Asked Questions (FAQ)?

Which Regulatory Authorities in Vietnam issuing HS GMP certification?

In Vietnam, the Vietnam Food Administration - Ministry of Health is the only department responsible for reviewing dossiers, evaluating and issuing a HS GMP certificate for HS GMP compliant facility according to the provisions of Decree No.15/2018/ND-CP and Circular 18/2019/TT-BYT.

Can traditional medicines and health supplement produce on the same production line?

According to Circular No.18/2019 TT-BYT, Herbal medicines and traditional medicines facility that have been granted GMP certificate for herbal medicines and traditional medicines, is allowed to produce health supplements with a dosage form similar to the certified dosage form. The provisions of this Clause shall come into force on the promulgated dates of the related legislative documents.

What are the basic contents of Good Manufacturing Practices for Health Supplement (HS GMP) guideline?

Quality System, Personnel, Premises and Equipments, Hygiene, Documentation, Production, Quality Control, Contract manufacture and analysis, Complaints and product recall, Self inspection

Is it necessary to invest in a laboratory for self-inspection when implementing HS GMP?

A laboratory is required, especially for a microbiological laboratory, to control the quality of products and the environment inside GMP facility. However, for the physicochemical characteristic of materials and products, it is not necessary to be fully equipped with machinery and equipment to self-test all criterias. With unusual criteria or expensive equipment, the laboratory can send the samples outside for testing in according to the contract.

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Representative Office: 156/1/1, Cong Hoa Street - Ward 12 - Tan Binh District - Ho Chi Minh City

GMPc VIETNAM JOINT STOCK COMPANY
TURNKEY CONSULTING SERVICE FOR HS GMP FACILITY

Head Office (Hanoi) : Blue Office, 4- BT1, Bui Xuan Phai Street, My Dinh 2 Ward, Nam Tu Liem District

Tel: 0243.787.2242 | CEO hotline: (+84) 982.866.668

Email: contact@gmp.com.vn