Standards for Renting a Pharmaceutical Manufacturing Factory (GMP-WHO)

Renting a GMP-compliant facility is essential for pharmaceutical, medical device, and nutraceutical manufacturers planning to operate legally in Ho Chi Minh City and nearby provinces. This guide outlines the GMP facility standards, required licenses, and periodic validations.

I. Construction & Design Standards

A GMP pharmaceutical facility must be designed to prevent contamination and ensure controlled cleanroom operations.

1. One-way production flow

• Ensures no cross-contamination between stages.

• Clear zoning for raw materials → production → packaging → finished goods.

• Minimizes reverse movement of personnel and materials.

2. Cleanroom construction materials

• Walls, ceilings, floors made from anti-dust, anti-static, seamless, and easy-to-clean materials (PU/EPS cleanroom panels).

• Rounded corner covings to avoid dust accumulation.

• Epoxy or antibacterial vinyl flooring.

3. Door systems & environmental control

• Automatic doors or airlock systems to maintain pressure stability.

• Air showers at critical cleanroom entrances.

II. Technical Systems Requirements

1. HVAC system with HEPA filtration

• HEPA filters ≥ 99.97% efficiency.

• Cleanroom classifications from ISO 8 → ISO 7 → ISO 6 depending on the process.

• Precise control of temperature, humidity, and pressure differentials.

2. Fire protection for cleanrooms

• Smoke/heat sensors compatible with cleanroom environments.

• Gas-based or water-sprinkler fire suppression per NFPA/TCVN standards.

3. Utility systems

• RO/RODI purified water system.

• Clean compressed air.

• Clean Steam for sterilization and equipment washing.

III. Licenses & Certifications Required

1. Investment Registration Certificate (IRC)

For foreign-invested or conditional investment projects.

2. GMP-WHO Certification

Issued by the Ministry of Health after full assessment of facility, equipment, and quality systems.

3. Pharmaceutical Manufacturing License

Required before any commercial production, granted by the Ministry of Health.

IV. Periodic Inspection & Maintenance

1. Air quality & microbiological validation

• Routine tests for viable and non-viable particles.

• Continuous monitoring of temperature, humidity, and pressure.

2. Equipment operation logbooks

• Every equipment must have a dedicated logbook.

• Includes maintenance, calibration, and cleaning records following SOPs.