New Facility Design, Set-Up & Layout Review

The cheapest time to fix a compliance problem is on the drawing board; the most expensive is after the concrete is poured. PharmExpert reviews and develops pharmaceutical facility designs — greenfield builds and brownfield modifications — ensuring personnel, material, product and waste flows, area classification, segregation and contamination control meet GMP expectations before construction locks them in.

Brownfield projects carry their own traps: existing constraints, legacy flows and live operations next door. We bring an inspector's eye and engineering depth to both, identifying flow conflicts, classification mismatches and qualification challenges early, when they can still be designed out cheaply rather than remediated later.

We develop or review the User Requirement Specification and layouts as the foundation for everything that follows, and advise on a facility concept that is compliant and efficient to operate — not compliant at the cost of unworkable. Contamination-control thinking is built in from the start, feeding the site's broader Contamination Control Strategy.

Crucially, we set up the qualification approach to follow the design, so commissioning and qualification flow logically from how the facility was conceived. Engaging us at the URS and conceptual stage is where this service delivers the greatest return; we complement, rather than replace, your architects and engineers.