Client
API and Fine Chemicals Manufacturer
Challenge
The client intended to establish a sterile injectable manufacturing facility meeting WHO-GMP and international regulatory expectations.
Scope of Work Execution
Sterile facility conceptual design
HVAC classification and cleanroom design
Water System (PW/WFI) planning
Equipment URS preparation
Validation Master Plan (VMP)
Qualification and commissioning
Solutions
ISHA’S GMP TURNKEY CONSULTANCY EUROPE LIMITED developed a complete sterile manufacturing roadmap, coordinated engineering design, utility qualification, cleanroom validation, and documentation management. Based on the company’s sterile-facility and validation expertise.
Impact & Outcomes
GMP-compliant sterile manufacturing infrastructure established
Reduced project execution risks
Regulatory inspection readiness achieved
Accelerated commercial production timeline