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How Do You Design a GMP-Compliant Production Facility?

Designing a GMP-compliant production facility isn’t just about aesthetics—it’s about hygiene, safety, and process flow. A poorly designed facility increases the risk of contamination, regulatory non-compliance, and production inefficiencies. Here’s how to build a layout that supports GMP from the ground up.

Why Facility Design Matters in GMP Compliance

  • Prevents cross-contamination and mix-ups

  • Supports efficient cleaning and maintenance

  • Protects product quality at every stage

  • Makes it easier to comply with ISO 22000, HACCP, and FSSC 22000

  • Reduces non-conformities during audits

Key Principles for GMP-Compliant Facility Design

1. Workflow and Process Flow

  • Design separate zones for raw materials, processing, packaging, and storage

  • Ensure one-way product flow from entry to exit

  • Avoid crossover between finished and raw goods

  • Minimize human and material movement across clean zones

2. Zoning and Segregation

  • Define zones: high-risk, low-risk, packaging, storage, etc.

  • Use physical barriers (walls, air curtains) to separate areas

  • Install color-coded floor markings and signage

  • Restrict access to critical zones

3. Hygienic Facility Layout

  • Smooth, non-porous walls and floors

  • Rounded corners for easy cleaning

  • Sloped floors with proper drainage

  • No open ceilings or exposed insulation

4. Equipment Design and Placement

  • Choose stainless steel or food-grade materials

  • Position equipment for easy access and cleaning

  • Prevent product build-up under or around machines

  • Avoid hard-to-clean gaps or joints

5. Personnel and Material Flow

  • Separate entry points for staff and materials

  • Use airlocks and changing rooms

  • Ensure handwashing and sanitizing stations at key points

  • Control pest entry with sealed doors and screened windows

6. Environmental Controls

  • Install HEPA filters or controlled air systems for clean areas

  • Monitor temperature and humidity in critical zones

  • Prevent condensation that could cause microbial growth

  • Ensure adequate lighting and ventilation

7. Utilities and Waste Management

  • Place water lines and drainage systems to prevent backflow

  • Label and maintain electrical, gas, and ventilation systems

  • Design waste disposal routes separate from clean areas

  • Provide designated bins for different waste types

8. Storage Design

  • Separate areas for raw materials, chemicals, and finished products

  • Use racks and pallets to keep items off the floor

  • Monitor temperature-controlled storage (cold rooms, dry goods)

  • Implement FIFO (First In, First Out) layout principles

9. Cleaning and Sanitation Areas

  • Designate zones for cleaning tools and chemicals

  • Avoid cross-use of cleaning equipment between zones

  • Provide proper drainage and ventilation in wash areas

  • Clearly label cleaning chemicals and store away from products

10. Documentation and Compliance

  • Keep updated facility layout drawings

  • Conduct routine GMP facility audits

  • Train staff on how layout supports hygiene and compliance

  • Prepare for audits with visual cues (maps, checklists, flow diagrams)

CAYS Scientific Helps You Design with Compliance in Mind
At CAYS Scientific, we help businesses:
✅ Design or redesign production facilities with GMP in focus
✅ Review layouts for ISO 22000, HACCP, and FSSC 22000 compatibility
✅ Identify hygiene and process flow risks before construction
✅ Train staff on facility-based compliance

📞 Contact CAYS Scientific today to ensure your facility is not just functional—but GMP-compliant from day one.

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