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Pharmaceutical production and trading is a conditional business line.
On April 6th, 2016, the National Assembly promulgated the Law on Pharmacy 105/2016/QH13 which clearly stated the conditions for granting the Certificate of Eligibility for Pharmacy business of pharmacy business establishments .
On November 22nd, 2018, the Ministry of Health issued Circular 35/2018/TT-BYT stipulating Good Manufacturing Practices (WHO GMP) for pharmaceutical products and pharmaceutical starting materials.
Subjects of GMP Application: Manufacturers including manufacturers of medicines, herbal pharmaceutical products, vaccines, biologicals, traditional pharmaceutical products, traditional ingredients, pharmaceutical starting materials
Pharmaceutical products can only be legally announced and circulated when they are manufactured at an establishment that has a Certificate of Good Manufacturing Practice (GMP) issued by the Ministry of Health.
In the current globalization trends of the Pharmaceutical Industry with stricter requirements from administration department, pharmaceutical facilities tend to comply with PIC/S-GMP and EU-GMP guidelines, one of the highest quality standards for Good Manufacturing Practices.
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05 NOTES

WHEN INVESTING ON PHARMACEUTICAL FACILITY

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MAIN REQUIREMENTS FOR
PHARMACEUTICAL FACILITY
COMPLYING WITH WHO-GMP GUIDELINE

•   Facility and Equipments Requirements
•   Quality Management System (QMS) Requirements
•   Starting Materials Requirements
•   Hygiene Requirements
•   Personnel and Training Requirements
•   Production, Storage and Distribution of products

PROCEDURE & SERVICE PACKAGES

Request for quotation

G01. Investment Project Proposal        

G02. Project Construction Drawings Design

G03. Construction Management and Supervision 

G04. Training - Drafting registration dossier

GE. General Contractor

GA. Turnkey Consulting Service A-Z

  • Creative, Professional and Effective Service, focusing on Practices guidance combined with Theoretical training (Training on the job).
  • Directly guide to Draft and Finalize the WHO GMP registration dossier that in compliance with DAV requirements.
  • Ensuring your workforce will confidently answer and defend to the GMP inspection team, as well as be equipped the WHO/EU GMP knowledge and practical skills to take control of the operation of the facility.
  • Most of project investors choose GMPc as turnkey consultant (A-Z) because this option brings the most optimal effect to them.
  • The TURNKEY CONSULTING service including 04 service packages: G01+G02+G03+G04
  • Based on the design and total estimated cost prepared by GMPc, investor has full right to decide appropriate construction contractor and equipment suppliers.
  • Although not being the Construction Contractor, GMPc still willing to take responsibility about the success and guaranteed certification of project.
  • About 30% investors choose GMPc as General Contractor of Design-Construction-Registration for Certificate.
  • In fact, there are some investors who invested up to 3 facilities, and they consistently choose to cooperate with GMPc under this service package
  • This package is especially suitable for Investors who have used GMPc's Services, fully understand the value and effectiveness that GMPc has brought to the Project.
  • 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? 
  • 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 Estimated Cost (Equipments/Supplies, Quantity, Unit Price, Total Cost)
  • Ensuring the Design Drawings and Total Estimated Cost are clear and objective, it can be used as STANDARD for bidding process.
  • 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 the Design Drawings and Contract.
Medicines, Herbal pharmaceutical product, Pharmaceutical starting materials, Vaccine, Biological products

NECESSARY INFORMATION ABOUT
GMP REGULATIONS
For manufacturer of traditional medicine and manufacturer of medicine,
herbal pharmaceutical product

Get free consultation

Medicine & Herbal pharmaceutical product

Traditional pharmaceutical products and traditional ingredients

1. Issuing authority
3. Minimum facility scale

Items

Drug Administration of
 Vietnam - Ministry of Health
Traditional Medicine Administration - Ministry of Health
2. Subjects of Application
Traditional medicines and
Traditional ingredients
>= 600 m2 (depends on the scale, number of production lines)
>= 600 m2 (depends on the scale, number of production lines)
4. Investment capital scale
> 10 billion VND
(depends on the scale,
number of production lines)
5.  Validity of certificate
3 years
3 years
6. Deployment time 
Total about 03 months (already had empty facility)
Total about 05 months (already had empty facility)
> 10 billion VND
(depends on the scale,
number of production lines)

ABOUT US

12

Years
experience

2 

Branches
Hanoi & HCMC

Projects
GMP facility

+250

See more: GMPc capacity profile

Website: www.gmp.com.vn

Established since May 25, 2011 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 250+ GMP-certified facility projects, which equals to more than 80% market share in Vietnam from 2011 to 2023. 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.

Why choose GMPc Vietnam?

3 main reasons that influence 80% of Vietnam GMP-project investors choosing GMPc as consultant!
  • The choice of all leading brands: DHG Pharma, Mediplantex, Nuclear Research Institute (NRI),...
  • Success rate of 100%.
  • Satisfied all investors.
  • Highly praised by authorities.

 1. Affirmed Reputation

  • Only one consultant for whole project
  • 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 GMP regulations; 
  • Meet the Authorities' requirements; 
  • Optimization of investment and operation cost; 
  • Controlled progress; 
  • Certification- success rate of 100% 

3. Taking responsibility

TYPICAL PROJECTS

Pharmaceutical factory - DHG Pharma( WHO GMP)

Address: Tan Phu Thanh IP, Chau Thanh A Commune, Hau Giang

See more: List of project consulted by GMPc Vietnam (2011-2023)

Pharmaceutical factory - Nippon Chemiphar ( JAPAN GMP) 

Address: 76 Doc Lap Avenue, An Phu, Di An, Binh Duong

>> See details
>> See details

Nuclear Research Institute (WHO GMP) 

Address: No.01 Nguyen Tu Luc, Da Lat, Lam Dong

Pharmaceutical factory - VCP Biotech (WHO GMP) 

Address: Thanh Xuan Commune, Soc Son District, Hanoi

Herbal medicine factory - HCM City Traditional Medicine Hospital 

Address: Ho Chi Minh City

National Institute of Medicinal Materials - MOH (WHO GMP) 

Address: 3B Quang Trung, Hoan Kiem District, Hanoi

Hi-tech pharmaceutical factory - CVI Pharma (WHO GMP)

Address: Hoa Lac Hi-Tech Park, Hanoi

Pharmaceutical factory - Mediplantex ( EU GMP)

Address: Hoa Lac Hi-Tech Park, Hanoi

>> See details
>> See details
>> See details
>> See details
>> See details
>> See details

CUSTOMER'S REVIEW

 100% GMPc's customer are satisfied with our services!
"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 Institute
National Institute Of Medicinal Materials (NIMM) – Vietnam Ministry Of Health
" CVI Pharma, a high-tech pharmaceutical factory project in Hoa Lac IDZ, is the great landmark project of CVI. We highly appreciate the capacity of GMPc's designing and consulting team, that is the reason why we choose GMPc as Design consultant for CVI Pharma facility. During the project, GMPc consulting team was enthusiastic and dedicate in drafting GMP registration dossier and brought our CVI Pharma to reach WHO GMP cetification.
We sincerely thank GMPc and hope you prosperity." 
 Pharmacist Phan Van Hieu - Board Chairman 
CVI Cosmetic and Pharmaceutical Joint Stock Company
www.cvi.vn
CVI Introduce
www.vienduoclieu.org.vn

FREQUENTLY ASKED QUESTIONS (FAQ)?

2. Validity of WHO GMP Certificate
The Certificate of Good Manufacturing Practice for drugs and medicinal ingredients is valid for 3 years from the date of issue, so enterprises need to submit an application for re-evaluation before the WHO GMP certificate expires.
1. Which administration department issue WHO GMP certificate in Vietnam?
In Vietnam, the Drug Administration of Vietnam (DAV) - Ministry of Health is the only administration department responsible for reviewing dossiers, assessing and granting Certificate of Good Manufacturing Practice, according to the provisions of Circular 35/2018/TT-BYT
3. Comparison of WHO GMP and EU GMP regulations
WHO GMP is a guideline of Good Manufacturing Practice issued by the World Health Organization. EU GMP is a guideline of Good Manufacturing Practice issued by European Union.

4. Should I choose a GMP turnkey consultancy company?
Investors often have to hire 3 to 5 consultants corresponding to each stage of the project, the cost accumulation is high but there is no consultancy which shall be responsible for whole stages. Choosing a turnkey consulting service implemented by a fully qualified and experienced consultant, to companion from the beginning to the end of project is a really necessary, useful, and highly effective solution.

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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 PHARMACEUTICAL 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

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