The Challenge
A global biopharmaceutical manufacturer supporting commercial drug production was operating under a multi-vendor logistics model. Inbound receiving, labeling, storage, and distribution were fragmented across providers, creating inconsistent processes, limited traceability, and operational inefficiencies.
As production volumes increased, the client needed a responsive, cGMP-compliant partner capable of consolidating operations, enhancing visibility, and scaling alongside evolving manufacturing demands without expanding internal infrastructure.
The Solution
Tobin Scientific partnered closely with the client to design and implement a fully integrated, customized operating model spanning inbound receiving, labeling, cold chain storage, inventory management, and distribution. Workflows were built around the client’s specific SOPs, quality standards, and production schedules, ensuring operational alignment at every step.
The program supports over 3,000 ambient pallet positions and approximately 180 refrigerated (2 to 8°C) pallet positions, with continuous inbound flow from vendors and internal transfers.
Scope of the Solution
Operational Scale, Storage, and Labeling
- Large scale cGMP warehousing supported by over 3,000 ambient pallet positions and 180 refrigerated (2 to 8°C) pallet positions
- Continuous inbound receipt from both external vendors and internal client sites
- High volume labeling operations supporting 15,000 to 20,000 labels per month with each level, case level, and pallet level labeling aligned to client specifications
- Label reconciliation and documentation verification prior to execution
- Controlled relabeling and secondary packaging adjustments
- Laundered cleanroom gown management
- Labeling performed within temperature-controlled environments as required
- System and documentation controls supporting full traceability
- Continuous temperature monitoring and controlled handling
- Scalable infrastructure designed to support increasing production demand
Inbound Receiving and Processing
- SOP aligned goods receipt workflows tailored to client specific requirements
- Documentation verification including PO and material checks
- Photo documentation captured at receipt and uploaded into the inventory system
- System entry and traceability within our managed QMS platform
- Segregation of materials requiring labeling prior to storage
- Integration efforts underway to support electronic data exchange with client ERP systems, including SAP environment
Inventory Management and Traceability
- Full batch, lot, and expiry tracking supported by FEFO management
- System based inventory visibility for client access
- RF enabled barcode scanning to support real time inventory accuracy and traceability
- Segregation of materials by processing status
Quality and Compliance
- Operations executed under SOP controlled procedures aligned to regulatory requirements
- Jointly developed procedures with client oversight
- Documentation review before and after labeling activities
- Deviation management and CAPA tracking within a formal QMS
- Real time client notification and resolution of quality events
Distribution and Manufacturing Support
- Multiple daily deliveries to manufacturing operations, typically up to three deliveries per day
- Pick, pack, and stage materials aligned to real time production schedules
- Reliable, high frequency material flow supporting commercial manufacturing timelines
Outcome
- Consolidated multiple vendors into a single, streamlined operating model
- Reduced operational complexity
- Enhanced end-to-end traceability
- Strengthened quality oversight and real-time inventory visibility
- Increased operational efficiency through standardized, controlled workflows
- Supported growing commercial production demand without disruption
- Maintained full cGMP compliance throughout all activities
- Delivered both stability and agility by operating as a true extension of the client’s team, positioning the program for scalable, long-term growth
Why Trust Tobin Scientific to Support Your cGMP Biopharma Manufacturing Operations
Tobin Scientific delivers compliant logistics and true partnership. Our team collaborates with you every step of the way to design flexible, customized solutions that evolve with your manufacturing strategy. With purpose-built cGMP infrastructure, scalable temperature-controlled environments, integrated quality systems, and responsive operational support, we provide the control, adaptability, and reliability biopharma manufacturers need to keep production moving with confidence.
