"Get GMP
 Get what you want"

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Cosmetic manufacture is a conditional business line.

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The Government has issued Decree 93/2016/ND-CP, effective from July 1, 2016, stipulating the conditions for manufacture of cosmetic products.

A cosmetic product can be legally announced and circulated only if it was produced at a facility with Certificate of eligibility for cosmetic manufacturing conditions. 

A facility that is eligible for cosmetic manufacturing conditions (minimum conditions), does not mean it can be granted CGMP ASEAN certification (higher requirements). However, a facility with CGMP ASEAN certification (issued by Ministry of Health) is obviously eligible for cosmetic manufacturing conditions.

CGMP ASEAN is "Good manufacturing practices for cosmetics" guidelines that was recognized by 10 member countries of ASEAN. With this certification, the cosmetic products can be annouced and circulated legally in ASEAN countries.

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Investing in Cosmetic Manufacturing Facility
05 things to be considered!

•   To affirm product quality
•   Improve the brand positioning
•   Medium to Large scale (minimum ~ 500m2)
•  Plenty investment budget, total invesment amounts >10 billions VND (depends on the scale)
•  Can be exportable, as well as be in compliance with other international regulations (ISO 22716) with out the need of upgrading.

The case Which you should invest in
CGMP ASEAN-compliant facility?

The case Which you should invest in
 Eligible facility for cosmetic manufacturing conditions?

• Comply with the provisions of Vietnamese law to be allowed to produce, announce and circulate cosmetics.
• Small scale (minimum area ~ 300m2)
• Simple manufacturing process
• Investment budget restrictions, from 3 to 10 billions VND (depends on the scale)
• Willing to take risk of upgrading the facility in the near future, due to the higher requirements of National Regulatory Authority.

Consulting Request

Consulting Request

10 differences between
Eligibility for cosmetic manufacturing conditions & CGMP ASEAN

 Get free consultation

Eligibility for cosmetic manufacturing conditions

CGMP ASEAN

1.Legal basis

3. Standard level

Items

Decree No. 93/2016/ND-CP

Circular No. 06/2011/TT-BYT

2.Issuing authority

Local Department of Health

Drug Administration of Vietnam - Ministry of Health

Low, comply with provisions of Vietnamese law

High – Be recognized by ASEAN member countries

4. Minimum facility scale

>= 300m2

>= 500m2

5. Investment capital scale

3-10 billions VND, depends on the scale, number of production lines

>10 billions VND, depends on the scale, number of production lines

6. Production conditions

 Cleanroom is not required (Require to control temperature and ventilation)

Cleanroom is required, Control 5 parameters: Temperature, Humidity, Pressure, Hygiene, Air Exchanges frequency

7. Quality Control

8. Key personnel requirements

9. Validity of certificates

10. Deployment time

Simple

Strictly, must have a microbiological criteria testing room

Few key personnels, simple requirements

In all departments, must have experiences, job qualifications.

Non-expiring certificate

3 years (re-evaluation every 3 years)

Total about 03 months (already had empty facility)

Total about 05 months (already had empty facility)

Sample Projects - 3D Models

Eligible facility for cosmetic manufacturing conditions

CGMP ASEAN cosmetic manufacturing facility

PROCEDURE & SERVICE PACKAGES

Request for quotation

G01. Preliminary-Overall Consultancy       

G02. Project Construction Drawings Design

G03. Construction Management and Supervision 

G04. Training - Drafting registration dossier

GE. General Contractor

GA.Turnkey Consulting Service A-Z

  • 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 CGMP inspection team, as well as be equiped the GMP ASEAN knowledge and practical skills to take control the operation of 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 detailed budgeting 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 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.
  • 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 CGMP ASEAN requirements

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!

  • The choice of all leading brands: Hanacos, Vimac, Topwhite, Linh Huong, ...
  • Success rate of 100%.
  • Satisfied all investors.
  • Highly praised by authorities.

 1. Affirmed Reputation

  • 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 cGMP regulations; 
  • Meet the Authorities' requirements; 
  • Optimization of investment and operation cost; 
  • Controlled progress; 
  • Certification- success rate of 100% 

3. Taking responsibility

Dang Duong Cosmetic - CGMP ASEAN

Address: Tan Tao IP, Binh Tan District, HCM City

Thai Huong Cosmetic (Linh Huong) - CGMP ASEAN 

TYPICAL PROJECTS

Address: Chuong My, Ha Noi

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

Hanacos Cosmetic - CGMP ASEAN 

Address: Tan Tao IP, Binh Tan District, HCM City

TopWhite Cosmetic - CGMP ASEAN

Address: Tan Phong Ward, 7 District, HCM City

Kosei Cosmetic - CGMP ASEAN 

Address: Yen My, Hung Yen

Dr Lacir Cosmetic- Eligibility for cosmetic manufacturing conditions

Address: Phuc Tho, Ha Noi

CUSTOMER'S REVIEW

"We highly appreciate the capacity of GMPc's designing and consulting team, that is the reason why we choose GMPc as Turnkey consultant for Thai Huong cosmetic manufacturing facility project. In fact, for all 3 Linh Huong facilities projects, we consistently choose GMPc as General Contractor of Design -Construction - Training and Certificate Registration.
 It demonstrated for our trust in reputation, capacity, as well as the value and effectiveness that GMPc has brought to our projects."

MrsNguyen Linh Huong
CEO of Linh Huong Cosmetic Branch 

"Building the manufacturing facility with CGMP ASEAN certification for Topwhite branch production requires a reputable partner, that are able to cover all project design, construction to recruitment support, GMP training and operating instruction.
We are impressed with GMPc's turnkey consulting service and sarisfied when choosing GMPc as General Contractor for our landmark project.
We hope GMPc all prosperity and always remains as the number 1 GMP consultant in VietNam"

Mrs Cao Thi Thuy Dung 
Founder, CEO of Top White Branch 

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

"Our mission is to become a leading company in the manufacturing industry of high quality cosmetic with CGMP ASEAN, ISO 22716 certification and aim to achieve CGMP FDA certification for exporting cosmetics to USA. For that purpose, we need a leading consultancy which are reputable and professional.
We were satisfied with the turnkey consulting model of GMPc, that was wonderful fit with our expectations. GMPc team supported us in every single stage of the project orientation, construction and M&E design to feasibility study, GMP training and operation.
I sincerely thank GMPc and hope you prosperity."

Mrs Vu Thi Thuy Linh
CEO - Board chairman of VIMAC Cosmetics JSC

Frequently Asked Questions (FAQ)?

When are cosmetic facilities required to achieve CGMP ASEAN certification issued by the Ministry of Health?

At this time, we don't have exact answer for your question. However, Ministry of Health tends to manage the cosmetic production more and more tightly. In fact, when evaluation of eligibility for cosmetic manufacturing conditions, the local departments of Health are demanding higher requirements, more closer to CGMP ASEAN requirements.

In Vietnam, Which department/agencies issue CGMP ASEAN certificate?

In Vietnam, the Drug Administration of Vietnam - Ministry of Health is the only agency responsible for reviewing dossiers, inspection and issuing CGMP ASEAN certificates for establishments that in compliance with CGMP ASEAN principles according to the provisions of Circular 06/2011/TT-BYT.

Is there the same rigorous level in audit procedure of the eligibility for cosmetic manufacturing conditions between local departments of Health?

In fact, there is no common scale/requirements between local departments of Health to evaluate and issue the certification of eligibility for cosmetic manufacturing conditions. The Hanoi and HCMC department of Health have more strict requirements and increasingly though project by project.

Some Non-governmental Organizations (usually issue ISO certificates) state that they can also issue CGMP ASEAN certificate. Should this certificate be done with them?

Some NGOs have done and been issuing ASEAN CGMP certificate, but they are not recognized. In fact, their assessment procedure is sloppy, lack of basis, and somewhat is "commercial". We recommend that customers should apply for CGMP ASEAN certificate via Ministry of Health to receive real value in investmrnt and operation.

Copyright © 2020 GMPc. All rights reserved.

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 CGMP 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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