A pharmaceutical facility is more than a building — it is a regulated environment where design, materials and validation decide whether the product can be made. Here is what building one in Mexico involves.
Why pharma in Mexico
Proximity to the US, competitive costs and a growing manufacturing base make Mexico a destination for pharmaceutical and medical-device facilities.
GMP and COFEPRIS
The design must meet Good Manufacturing Practice (GMP) and COFEPRIS regulation, plus international standards (FDA, EU GMP) for export.
Cleanrooms and HVAC
Production areas require ISO 14644 cleanrooms with HVAC, pressurization and particle control designed as part of the process — not added afterward.
Sanitary materials and finishes
Floors, walls and joints must be washable, crack-free and durable; finish details are critical to compliance.
Validation and qualification (IQ/OQ/PQ)
The facility is handed over validated: installation, operational and performance qualification. One team that designs, builds and validates closes the loop.
CTECP
CTECP delivers turnkey cleanrooms and controlled environments in Mexico, integrating shell, MEP and validation, with 250+ projects and 580,000+ m² built.