Pharmaceutical Warehouse Automation
GxP Compliant. Audit Ready. Always.
Pharmaceutical facilities demand the highest standards of compliance, documentation, and quality. MTLI Group of Companies delivers pharmaceutical warehouse automation - GxP-compliant infrastructure for manufacturing, distribution, and storage operations.
We Understand Your Pain Points
Regulatory Compliance
FDA, DEA, and international regulations require validated systems and documentation.
Serialization
Track-and-trace requirements demand integration with automation systems.
Controlled Substances
DEA-compliant storage with security and access controls.
Temperature Sensitivity
Many products require precise temperature control throughout the supply chain.
How MTLI Solves These Challenges
GxP Facility Construction
Facilities designed and built to pharmaceutical standards.
- Clean room construction
- Controlled environments
- GMP facility design
- Validation documentation
- FDA-ready facilities
Pharmaceutical Storage
Storage systems for pharmaceutical products and materials supporting healthcare distribution solutions across the supply chain.
- Controlled storage
- Temperature mapping
- DEA-compliant cages
- Clean room racking
- Serialization integration
Validated Automation
Automation systems with IQ/OQ/PQ documentation, engineered as GAMP compliant warehouse systems.
- Validated ASRS
- Track-and-trace conveyors
- Clean room automation
- Serialization systems
- 21 CFR Part 11 compliant
Why Work With One Pharmaceutical Infrastructure Partner
Pharmaceutical projects that split construction, racking, and automation across vendors create gaps in validation documentation and audit readiness. The benefits include:
- One point of contact from design through commissioning
- Construction, storage, and automation scopes stay coordinated on one schedule
- Fewer handoffs between trades reduces validation and documentation gaps
- One team accountable for IQ/OQ/PQ documentation across the full project
- Maintenance from the same team that installed the system
Pharmaceutical Expertise
MTLI Group brings deep expertise in pharmaceutical warehouse automation and healthcare distribution solutions. We understand your unique challenges, compliance requirements, and operational demands.
- GxP-compliant construction
- IQ/OQ/PQ documentation
- Clean room expertise
- Temperature-controlled systems
- DEA-compliant storage
- FDA audit support
Signs Your Facility Needs Pharmaceutical Warehouse Automation
Pharmaceutical operators usually reach out once these signals show up in daily operations:
- Manual tracking makes serialization and track-and-trace harder to sustain
- Audit findings cite gaps in validation or IQ/OQ/PQ documentation
- Temperature excursions occur between receiving and controlled storage
- DEA or controlled substance storage capacity is running out
- Clean room or GMP space is at capacity with no expansion planned
GAMP Compliant Warehouse Systems We Deploy
MTLI installs automation validated to GAMP 5 principles, with IQ/OQ/PQ documentation built into the project, not added after installation.
Validated ASRS
Automated storage and retrieval systems are commissioned with complete IQ/OQ/PQ documentation, providing reliable inventory management while meeting pharmaceutical validation requirements.
Track-and-Trace Conveyor Systems
Integrated conveyor systems capture serialization data at every transfer point, ensuring complete product traceability and supporting regulatory compliance across the supply chain.
Clean Room Automation
Automation solutions are designed for controlled environments, enabling efficient material handling while maintaining contamination control and GMP standards.
21 CFR Part 11 Compliant Systems
Electronic records and signature-enabled automation support FDA compliance by ensuring secure data management, audit trails, and validated system performance.
GAMP 5 Validated Automation
MTLI deploys GAMP compliant warehouse systems engineered to GAMP 5 principles, with validation and IQ/OQ/PQ documentation incorporated throughout the project lifecycle.
How Our Pharmaceutical Warehouse Automation Comes Together
Assess
We review your validation history, serialization requirements, and controlled substance storage needs.
Design
Our team lays out GxP construction, storage, and automation sized to your compliance and throughput requirements.
Install
Clean room and validated automation installation follows documented IQ/OQ protocols from day one.
Support
Ongoing maintenance and PQ support keep validated systems audit-ready.
Pharmaceutical Warehouse Automation for Every Facility Type
Pharma Distributor, DEA-Compliant DC
The Challenge
A pharmaceutical distributor needed a facility to handle controlled substances with full DEA compliance and track-and-trace capability.
The Solution
MTLI constructed a 200,000 SF distribution center with DEA-compliant vault storage, temperature-controlled zones, and serialization-integrated automation.
Results
- DEA Schedule II-V compliant
- Full serialization
- Zero audit findings
- Same-day shipping capability
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Ready to Transform Your Pharmaceutical Operations?
Contact MTLI Group to discuss your project requirements and get a customized solution.
Common Questions, Answered
What are GAMP compliant warehouse systems?
GAMP compliant warehouse systems are automation platforms validated against GAMP 5 principles, with documented qualification at every stage so the equipment holds up to FDA and internal audit review.
What does MTLI do for pharmaceutical facilities?
Everything between the walls: racking, automation, construction, electrical, installation, relocation, and lifecycle maintenance, delivered as one accountable team. Projects range from under $100K upgrades to $100M+ turnkey programs.
Can you work inside a live pharmaceutical operation?
Yes, that is where we do most of our work. Phased sequencing, off-shift crews, and strict containment keep your operation running, and our record includes a 1,000,000+ sq ft healthcare transition completed with zero disruption.
Do you understand the compliance side of pharmaceutical?
Codes, permits, engineered drawings, and safety standards are handled by MTLI for every project, with certified supervisors on site daily and documentation maintained as we build.
Can pharmaceutical warehouse automation integrate with our existing systems?
Yes. MTLI designs automation solutions that integrate with existing WMS, ERP, serialization platforms, temperature monitoring systems, and facility infrastructure to improve efficiency without disrupting operations.
How do we start?
Book a consultation with our team to discuss your facility requirements, compliance goals, and automation needs. Visit our Contact page, email us at info@mtligroup.com, or call 416-293-2176 to schedule a consultation with one of our warehouse automation specialists.