10 differences between
Eligibility for cosmetic manufacturing conditions & CGMP ASEAN
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
Cleanroom is not required (Require to control temperature and ventilation)
Cleanroom is required, Control 5 parameters: Temperature, Humidity, Pressure, Hygiene, Air Exchanges frequency
8. Key personnel requirements
9. Validity of certificates
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)