What is GMP Warehouse Design?

Our service provides expert design of GMP-compliant pharmaceutical warehouses, focusing on optimal layouts, storage types, personnel and material flow segregation, and traceability systems for safe and compliant storage of raw materials, APIs, intermediates, and finished products.

Why is it Critical?

GMP-compliant warehouse design ensures product integrity, prevents contamination, and meets stringent regulatory standards, safeguarding patient safety and supporting audit readiness.

Our Role in Your Success

As a trusted CRO, Indivirtus Healthcare Services delivers expert-led warehouse design solutions, optimizing storage functionality and ensuring compliance with global GMP standards for pharmaceutical facilities.

Our Expert Design Approach

At Indivirtus Healthcare Services, our warehouse design consulting is led by experienced GMP experts who specialize in creating regulatory-compliant storage solutions. We focus on optimal layout planning, segregation of personnel and material flows, hazardous and cold storage accommodations, and advanced traceability systems to ensure full compliance with global standards.

Our tailored approach includes detailed assessments of your facility’s needs, whether for new construction or upgrades, delivering practical and efficient designs that enhance operational workflows and ensure audit-ready compliance.

Warehouse Design Deliverables

GMP-Compliant Warehouse Layout Drawings: Detailed blueprints for optimized storage design.

Storage Zone Classification & Specifications: Defined zones for raw materials, APIs, and finished products.

Personnel and Material Flow Maps: Segregated flow plans to prevent cross-contamination.

Traceability & Barcode Integration Plan: Systems for full material traceability.

Cold & Hazardous Material Storage Design: Specialized solutions for temperature-sensitive and hazardous materials.

Regulatory Compliance & Global Standards

Our warehouse design services align with stringent global standards, ensuring your storage facilities meet regulatory requirements and are audit-ready. By adhering to industry-leading guidelines, we deliver designs that support compliance and enhance operational confidence for international markets.

  • EU GMP: European guidelines for good manufacturing practices in storage.
  • US FDA 21 CFR: U.S. regulations for pharmaceutical manufacturing and storage.
  • WHO TRS 1019: Global GMP guidelines for quality assurance in warehousing.
  • ISPE Baseline Guide Vol 6: Industry best practices for pharmaceutical facility design.
  • ICH Q7: Good manufacturing practice guide for active pharmaceutical ingredients.

Applications & Use Cases

Our warehouse design services are vital for pharmaceutical manufacturers building new facilities or upgrading existing ones to ensure GMP compliance. Ideal for managing raw materials, APIs, intermediates, and finished products, our solutions support cold chain logistics, hazardous material storage, and traceability. Key use cases include designing multi-product warehouses, preparing for regulatory audits, and optimizing storage for global market expansion.

Why Choose Indivirtus Healthcare

Indivirtus Healthcare Services is a trusted partner for pharmaceutical manufacturers, delivering GMP-compliant warehouse design solutions backed by certified experts with global regulatory experience. Our designs ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.

With a commitment to industry best practices, we empower your facility with safe, efficient, and compliant storage solutions, driving regulatory success and operational excellence.

Frequently Asked Questions

Frequently Asked Questions

Why is a GMP-compliant warehouse layout important?

A GMP-compliant warehouse layout ensures materials are stored and handled according to pharmaceutical standards, reducing contamination risk and ensuring regulatory compliance.

How is hazardous material storage handled in pharma warehouses?

We design dedicated zones with appropriate insulation, ventilation, and safety protocols for storing flammable, corrosive, or toxic materials in compliance with global safety standards.

What systems are used for material traceability in warehouses?

Traceability is achieved through barcode or RFID systems integrated with warehouse management systems (WMS) to track materials from receipt to dispatch.

How do you ensure proper personnel flow in a GMP warehouse?

Personnel movement is managed by segregated entry/exit zones, gowning areas, and unidirectional flow pathways to prevent cross-contamination and ensure hygiene.

Can this service support both Greenfield and Brownfield pharma projects?

Yes, our warehouse design service is tailored for both Greenfield and Brownfield pharmaceutical projects, including facility upgrades and new constructions.

What does the warehouse design consulting service include?

Our service includes GMP-compliant layout planning, storage zone classification, personnel and material flow segregation, traceability and barcode integration, and specialized designs for cold and hazardous material storage.

Who benefits from GMP-compliant warehouse design?

Pharmaceutical manufacturers building new facilities or upgrading existing ones, particularly those managing raw materials, APIs, intermediates, or finished products, benefit from our compliant and efficient designs.

How does the service ensure regulatory compliance?

Our designs align with EU GMP, US FDA 21 CFR, WHO TRS 1019, ISPE Baseline Guide Vol 6, and ICH Q7, ensuring your warehouse meets global regulatory standards and is audit-ready.

What deliverables are provided with the warehouse design service?

Clients receive GMP-compliant layout drawings, storage zone specifications, personnel and material flow maps, traceability and barcode integration plans, and cold/hazardous material storage designs.

Can the warehouse design be customized for our facility’s needs?

Yes, our designs are tailored to your facility’s specific requirements, including storage types, material flows, and regulatory needs, ensuring practical and compliant solutions.

How does the service support cold chain or hazardous material storage?

We provide specialized designs for cold and hazardous material storage, including temperature-controlled zones and safety protocols, ensuring compliance with GMP and regulatory standards.