Get what you want"
Cosmetic manufacture is a conditional business line.
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.
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.
• 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.
3. Standard level
Decree No. 93/2016/ND-CP
Circular No. 06/2011/TT-BYT
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
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
Strictly, must have a microbiological criteria testing room
Few key personnels, simple requirements
In all departments, must have experiences, job qualifications.
3 years (re-evaluation every 3 years)
Total about 03 months (already had empty facility)
Total about 05 months (already had empty facility)
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.
3 main reasons that influence 80% of Vietnam GMP-project investors choosing GMPc as consultant!
Address: Tan Tao IP, Binh Tan District, HCM City
Address: Chuong My, Ha Noi
Address: Tan Tao IP, Binh Tan District, HCM City
Address: Tan Phong Ward, 7 District, HCM City
Address: Yen My, Hung Yen
Address: Phuc Tho, Ha Noi
"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."
"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"
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."
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, 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.
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 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.
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