The GMP-compliant factory system has now become a mandatory requirement for enterprises in the pharmaceutical, food, and cosmetic industries in Vietnam. This standard is not only a legal regulation but also a foundation to ensure safety, product quality, and brand reputation in an increasingly competitive market.
A factory designed according to GMP standards allows full control over the entire production process from input materials to finished products ensuring that every stage is carried out under appropriate conditions of hygiene, temperature, humidity, and pressure. Compliance with GMP principles right from the design phase helps enterprises minimize future renovation costs, avoid post-construction modifications, and quickly meet the inspection and licensing requirements of the Ministry of Health and international organizations.
As an experienced unit in a series of GMP-certified factory projects, BIC recognizes that designing factories according to GMP standards not only helps enterprises comply with regulations but also brings long-term benefits: reducing operational risks, optimizing production lines, enhancing competitiveness, and expanding export opportunities. The following article provides investors with a comprehensive overview of GMP standards currently applied in Vietnam and the key design principles to ensure investment efficiency and sustainable development.
GMP (Good Manufacturing Practice) is a set of principles proposed by the World Health Organization (WHO) to ensure that products are manufactured under controlled conditions that meet safety and quality requirements. GMP is applied in many fields such as pharmaceuticals, food, cosmetics, medical devices, animal feed, and even food packaging production.
In Vietnam, the application of GMP is regulated by the Ministry of Health and the Ministry of Agriculture and Rural Development. Depending on the industry, enterprises must comply with one or several GMP standards:
- GMP-WHO: Applied in the pharmaceutical industry. This standard was issued by the Ministry of Health of Vietnam in 2004, requiring all drug manufacturing factories to obtain GMP-WHO certification before being allowed to operate.
- GMP-ASEAN: Applied in the cosmetic and functional food sectors, focusing on hygiene conditions, production environment, and quality management.
- GMP-Codex: Applied in the food industry, based on the guidelines of the Codex Alimentarius Commission under FAO/WHO. This standard is often combined with HACCP or ISO 22000 to ensure food safety.
- GMP ISO 22716: Applied in the export cosmetic manufacturing industry, helping enterprises meet the requirements of markets such as the EU, Japan, and the United States.
Applying the correct GMP standard right from the design construction stage not only helps enterprises comply with the law but also creates a foundation for international cooperation, enhances brand reputation, and expands market reach.
Designing a GMP-compliant factory is not simply about creating a clean production space—it is about controlling the entire production chain, including materials, personnel, equipment, movement flow, and technical systems. Every design element plays a crucial role in maintaining a stable production environment, preventing cross-contamination, and ensuring product quality according to international standards.
The “one-way flow” principle is fundamental in every GMP-compliant factory. The movement of raw materials, products, and personnel must follow a continuous sequence from material input, processing, and packaging to finished goods output without intersection or reverse direction.
This layout helps eliminate cross-contamination risks, reduces confusion between clean and unprocessed areas, and facilitates easier inspection and supervision. In large-scale factories, the design drawings should clearly indicate dedicated routes for material transport, personnel movement, and product dispatch to avoid operational conflicts.
A GMP factory must be divided into independent functional areas corresponding to each stage of production, including:
- Raw material receiving area
- Production area
- Quality control laboratory (QC/QA)
- Packaging area
- Finished goods warehouse
- Utility and technical area
- Administrative and office area
Each area must maintain suitable environmental conditions such as temperature, humidity, and cleanliness depending on its function. For example, mixing and packaging rooms in pharmaceutical factories must be sterile, while warehouses may maintain standard cleanliness levels.
This zoning approach improves productivity, reduces contamination risks, and simplifies cleaning and maintenance.
Cross-contamination control is one of the core requirements of GMP-compliant factory design. Contamination can arise from air, personnel, materials, or equipment. Therefore, the design must ensure the separation of flows.
High-risk areas such as weighing, mixing, and packaging rooms should be equipped with pressure control, HEPA filtration, and airflow management systems. Cleanrooms should maintain positive pressure relative to surrounding zones to prevent dust or microorganisms from entering. Independent air supply and return systems are required to prevent airflow from dirty to clean areas.
Airlocks or air showers between clean and non-clean areas are essential to minimize contamination risks. These buffer rooms ensure that only one door opens at a time, maintaining directional airflow and avoiding unwanted air exchange.
All internal surfaces walls, ceilings, floors, doors, pipes, and equipment, must be smooth, non-porous, and easy to clean.
- Wall and floor junctions should be curved or beveled.
- Surfaces must be waterproof, non-absorbent, and resistant to chemicals.
- Floors should be coated with anti-slip epoxy, sloped appropriately for drainage.
- Pipes and cables should be installed externally to simplify inspection.
Regular cleaning and maintenance procedures must be documented in GMP records for traceability and quality assurance.
The overall layout of a GMP factory determines its ability to achieve certification. A scientific design ensures smooth operation and serves as the foundation for inspection and compliance evaluation. The design must follow three key principles: logical flow, one-way direction, and non-intersection.
The production process must follow the manufacturing sequence from raw material receiving, testing, processing, packaging, storage, to finished product output. Separate routes must be arranged for:
- Personnel movement (through gowning and sanitation areas)
- Raw material transport (through designated transfer zones)
- Finished product flow (toward warehouse or dispatch area)
- Waste disposal (through independent routes that do not intersect with clean zones)
Airlocks or air showers should be installed between zones with different cleanliness levels. These maintain clean air conditions using HEPA filtration and pressure differentials (typically 10–15 Pascal). Interlocked doors prevent sudden pressure changes and unfiltered air exchange.
Personnel must follow a strict entry procedure before entering clean areas:
1. Change clothes in Gowning Room
2. Wear protective equipment (mask, cap, shoes)
3. Wash and disinfect hands
4. Pass through the airlock or air shower before entry
No reverse movement is allowed between zones without appropriate hygiene procedures.
- Raw materials move from receiving → testing → approved storage → production.
- Finished products move from packaging → quarantine → QC release → warehouse.
- Waste follows separate sealed routes to the waste treatment area.
Pass boxes equipped with UV sterilization and interlocked doors are used between transfer points to prevent microbial contamination.
Air must flow from cleaner to less clean areas under positive pressure. The HVAC system must maintain stable airflow, prevent turbulence, and ensure HEPA-filtered air supply.
A scientific and logical layout ensures smooth operation, minimal maintenance costs, and compliance with GMP standards.
All materials must be smooth, non-absorbent, non-shedding, and resistant to moisture and chemicals.
- Walls/Ceilings: Use PU or EPS sandwich panels with antibacterial coatings.
- Floors: Use epoxy or granite tile surfaces, anti-slip and chemical-resistant.
- Corners: Should be rounded or beveled for easy cleaning.
- Doors/Windows: Must be airtight, rubber-sealed, and corrosion-resistant.
Wood and untreated steel should not be used in production areas as they are prone to mold and rust.
The HVAC system regulates temperature, humidity, and pressure while filtering air through HEPA filters with 99.97% efficiency at 0.3 µm. Ducts should be smooth and placed outside cleanrooms for maintenance. Environmental parameters must be continuously monitored by sensors connected to a central control system.
The water system must deliver purified water through multi-stage filtration, reverse osmosis (RO), UV disinfection, and deionization. Drainage systems should have a 1–2% slope, odor traps, and be made of stainless steel (304/316L). Wastewater must be treated before discharge to meet environmental standards.
Electrical systems must comply with TCVN 7447-7-707:2010. Conduits and fixtures must be sealed and dustproof (IP65 rating) and equipped with emergency lighting and backup power.
- Production areas: minimum 300 lux
- QC and packaging areas: minimum 500 lux
LED panels with neutral white light are recommended for accurate color visibility.
Compressed air must be generated by oil-free compressors and filtered through fine filters and moisture separators. Piping should be made of stainless steel or aluminum alloy, corrosion-resistant, and pressure-tested. Steam used for sterilization must be clean, non-metallic, and properly insulated to prevent condensation.
A GMP-compliant factory must include several essential functional areas, each serving a specific role in the overall manufacturing and quality control process. Proper zoning not only supports efficient workflow but also ensures compliance with hygiene and contamination control standards.
This is the first point of contact for all input materials. It must be designed to facilitate easy inspection, weighing, and sampling before storage. The layout should include:
- A receiving area protected from weather and dust.
- A quarantine zone for unapproved materials awaiting QC results.
- A separate storage area for approved materials, equipped with proper temperature and humidity control systems.
- Distinct storage zones for hazardous, flammable, or temperature-sensitive materials.
All material movement from receiving to production must be clearly documented and traceable according to GMP recordkeeping principles.
The production area is the heart of the factory, where raw materials are processed into semi-finished or finished products. Depending on the product type, this zone may include mixing rooms, filling rooms, drying areas, sterilization chambers, or packaging lines.
The area must comply with the required cleanliness class, air pressure, temperature, and humidity standards. Walls, floors, and ceilings must be constructed with seamless, easy-to-clean materials. The movement of personnel and materials within this area must follow a strict one-way direction to prevent cross-contamination.
The QC/QA section ensures that every batch of raw materials, semi-finished products, and final products meets specified quality standards.
QC laboratories must be located separately from production areas to avoid interference from vibrations, dust, or temperature fluctuations. They should be divided into functional sections such as:
- Physical and chemical analysis room
- Microbiological testing room
- Instrument room
- Sample storage room
QA offices manage documentation, monitor production records, and ensure that all processes comply with GMP requirements.
After production and QC approval, products are transferred to the packaging area. This section must be clean, well-lit, and arranged logically according to the type of packaging material.
The finished goods warehouse should be equipped with environmental control systems to maintain product stability and quality. The design must include:
- Separate areas for quarantine, approved, and rejected goods.
- Controlled temperature and humidity levels.
- FIFO (First In – First Out) management system for inventory rotation.
This area houses all supporting systems necessary for stable factory operation, including:
- HVAC equipment and air compressors
- Water purification and wastewater treatment systems
- Boilers and steam systems
- Electrical control panels and backup power supply
The technical area should be isolated from production zones but must allow easy access for maintenance and monitoring. All pipelines and ducts connecting to cleanrooms should be sealed and properly labeled for identification.
Personnel entering clean areas must pass through changing rooms and airlocks designed in sequence:
- Changing area for removing street clothes
- Clean gowning area for donning sterile garments
- Air shower or handwashing area
Administrative offices, meeting rooms, and rest areas must be located outside production zones but conveniently connected for workflow coordination.
Designing and constructing factories according to GMP standards brings both short-term and long-term advantages to enterprises, not only in terms of compliance but also in improving operational efficiency, competitiveness, and reputation.
A GMP-compliant design enables enterprises to quickly obtain certification from the Ministry of Health, facilitating legal production and market entry. Meeting GMP-WHO, GMP-ASEAN, or GMP-Codex standards ensures that products are accepted in domestic and international markets.
Compliance also helps enterprises avoid costly delays, redesigns, and inspection failures, ensuring smooth project approval and stable operation from the start.
GMP design ensures all production stages from raw material input to final packaging—are carried out in a clean and controlled environment. This significantly reduces the risks of contamination, mix-ups, and quality defects, ensuring consistent product quality and consumer safety.
A stable and monitored production environment helps minimize batch variability, strengthen brand trust, and meet export standards for high-demand markets such as the EU, US, and Japan.
GMP-compliant factory design emphasizes logical layout, one-way flow, and efficient movement between zones. This not only minimizes material waste and labor movement but also improves workflow and productivity.
By integrating modern systems such as HVAC automation, environmental monitoring, and cleanroom technology, enterprises can reduce energy consumption, downtime, and maintenance costs.
Factories meeting GMP standards demonstrate professionalism and responsibility toward quality, hygiene, and safety. This enhances the enterprise’s reputation with customers, partners, and regulatory agencies.
For export-oriented enterprises, GMP certification serves as a “passport” to enter international markets, fostering credibility with global clients and investors.
GMP design aligns with sustainable development trends by integrating energy-saving systems, waste management, and environmental protection solutions. Efficient ventilation, proper lighting design, and smart material selection help reduce carbon emissions and operational costs.
Investing in a GMP-standard factory is not only a compliance requirement but also a strategic decision for long-term growth, sustainability, and competitiveness in the global supply chain.
Designing and constructing factories according to GMP standards is a critical step for enterprises in industries such as pharmaceuticals, food, and cosmetics. Beyond meeting legal and regulatory requirements, GMP ensures product quality, operational safety, and market credibility.
With its extensive experience in designing GMP-certified projects, BIC is committed to providing comprehensive design solutions that meet Vietnamese and international GMP standards helping investors optimize costs, accelerate certification processes, and build sustainable, future-ready manufacturing facilities.
