Cleanroom contractor in Vietnam: rules for buyers

By ZY Cleanroom · Updated 2026-11-01 · Sources at the end of the page

Which rules apply to your facility

The National Assembly passed the amended Law on Pharmacy on 21 November 2024. It took effect on 1 July 2025, except for the rules on drug registration and the rights and responsibilities of certain pharmaceutical businesses (Tilleke & Gibbins).

Circular 28/2025/TT-BYT on Good Manufacturing Practices for medicinal products and medicinal materials also took effect on 1 July 2025. It replaces Circular 35/2018/TT-BYT and Circular 12/2022/TT-BYT. It sets GMP principles and standards according to WHO, EU, PIC/S and other stringent authorities, and it covers the dossier, on-site evaluation and classification of compliance (Circular 28/2025/TT-BYT, via LuatVietnam).

Vietnam is not on the PIC/S list of participating authorities (PIC/S, checked 31 October 2026). Hospitals fall under Decree 96/2023/ND-CP of 30 December 2023 on medical examination and treatment, in force from 1 January 2024 (LuatVietnam).

Who builds cleanrooms here

Owners of drug and medicinal material plants that apply for GMP assessment under the circular are the clearest buyers. Hospitals with operating and intensive care rooms are the other group. The amended law also lets foreign-invested enterprises import drug materials for contract manufacturers in Vietnam (Tilleke & Gibbins).

Which cleanroom standard to name in the brief

Vietnam's national series TCVN 8664 follows ISO 14644. Part 1, TCVN 8664-1:2011, is titled as equivalent to ISO 14644-1:1999, the first edition of the classification standard (Luat Minh Khue). If the owner's brief cites ISO 14644-1:2015, say so in the scope, so that room classes are set and tested on the same basis.

What to send for a first scope

Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the owner is applying for GMP assessment under Circular 28/2025/TT-BYT, and whether the rooms are sterile or non-sterile. Name the ISO 14644-1 edition in the brief and say whether the building is new or existing.

Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.

Who does the site work

Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.

Related guides

• The Cleanroom Project Lifecycle
• Cleanroom cost per m²: published ranges by ISO class
• What a cleanroom costs to run: energy, filters and testing
• Building a cleanroom inside an existing building
• Turnkey cleanroom contractor
• Room list builder

Sources

• PIC/S, list of participating authorities (checked 31 October 2026)
• Tilleke & Gibbins, Vietnam amends Law on Pharmacy (checked 31 October 2026)
• LuatVietnam, Circular 28/2025/TT-BYT of 1 July 2025, Good Manufacturing Practices for medicinal products and medicinal materials (English; checked 31 October 2026)
• LuatVietnam, Decree 96/2023/ND-CP of 30 December 2023 elaborating the Law on Medical Examination and Treatment (checked 31 October 2026)
• Luat Minh Khue, TCVN 8664-1:2011 (ISO 14644-1:1999), cleanrooms and associated controlled environments, Part 1 (checked 31 October 2026)