The Challenge

A client in the biologics space was moving rapidly from contract manufacturing (CMO) to in-house production as they approached commercial readiness. Without a formal materials management program, they faced gaps in inventory control, compliance, and operational scalability. The transition required a GxP-compliant framework for handling materials from receipt through production, storage, and outbound shipping, all within a tight timeline.

Our Approach

We were brought in to design and implement a comprehensive materials management program aligned with GxP standards and future commercial operations.

Key priorities included:

• Mapping the end-to-end GxP material flow to ensure alignment with industry guidance and regulatory requirements
• Defining organizational structure with clear departmental responsibilities for materials management
• Developing SOPs and forms to standardize receiving, storage, issuance, and shipping processes
• Building electronic templates to manage inventory and data flow in preparation for a future ERP implementation
• Providing facility layout recommendations for optimal material handling and storage capacity

The Solution

Delivered a complete, scalable materials management framework:

• Process Design – Developed an ideal-state process flow for all material movements, from inbound receipt to outbound shipment
• GxP Documentation – Created or enhanced 13 SOPs and 5 forms covering:
  • Inbound Receiving - inspection and release through the Quality System
  • Storage - ambient and temperature-controlled environments
  • Issuing Goods - controlled issue to production
  • Outbound Shipping - compliant preparation and documentation
• Organizational Planning – Designed a personnel sourcing strategy with org chart, functional departments, and defined responsibilities
• System & Layout Preparation – Delivered electronic templates for inventory management and recommended facility layout improvements to meet regulatory and operational needs

Results

• Established a GxP-compliant materials management program to support the transition to in-house manufacturing
• Delivered 13 SOPs, 5 forms, and electronic tools to manage inventory and data flow
• Provided facility design recommendations to optimize material flow and compliance
• Identified additional documentation needs and risk mitigation strategies for future facility readiness
• Created a scalable framework for eventual ERP integration