Leading Life Sciences
The Value of Precis: A Process-First Planning Approach to Successful GMP Facility Design Issue 3
Precis projects are built on a foundation of collaboration, technical rigor, and early alignment. By embedding process architecture at the center and surrounding it with in-house engineering expertise, our team helps clients define their vision, protect their investment, and move from blank page to build-out with confidence.
Introduction For many organizations, planning a new Good Manufacturing Practice (GMP) facility starts with a blank page—an exciting yet often overwhelming challenge. Whether it’s a fast-growing pharmaceutical company developing its first manufacturing space or a life sciences firm expanding its infrastructure, the process is complex. The start of this endeavor involves navigating regulatory standards, defining operational needs, and making hundreds of critical decisions. Importantly, this early stage is also when the organization must consider, not only the functional and technical requirements of the facility, but the broader vision it represents. In some cases, the focus is solving immediate project needs within an existing footprint. In others, particularly when building a new facility or expanding significantly, the project carries greater aspirations, serving as a physical embodiment of the company’s values, culture, and strategic ambitions. From the outset, planning must align with both the core operational goals and the long-term vision for how the space will be used and perceived, projecting the company’s identity and supporting its evolution.
When approached with the right framework, however, GMP facility planning can be efficient, collaborative, and strategically invaluable. GMP projects vary widely in scope and complexity, ranging from API and oral solid dose (OSD) manufacturing to sterile and parenteral production, clinical-scale operations to full commercial manufacturing, and a diverse array of specialized support functions. Each modality presents its own regulatory, technical, and operational considerations. At Precis, our team brings deep, cross-functional expertise to these challenges, having partnered with clients across the industry—from global pharmaceutical leaders to fast-growing innovators—to guide complex projects from concept to completion. The following overview outlines the key phases of planning a GMP facility and highlights how Precis’ multidisciplinary approach helps organizations move forward with clarity and confidence.
Phase 1: Incubation - From Questions to Concept Every successful facility begins by understanding what the organization is trying to achieve.
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