Client
Pharmaceutical Formulation Manufacturer
Scale
35,000 sq. ft.
Delivery
14 Months
Compliance
14 Months
Challenge
The client planned to establish a new WHO-GMP-compliant manufacturing facility for tablets, capsules, and oral liquids but lacked expertise in facility design, equipment selection, utility planning, and regulatory compliance.
Scope of Work Execution
Feasibility study
Detailed project report (DPR)
Facility layout and cleanroom design
HVAC and utility system design
Equipment selection and procurement support
Qualification and validation
GMP documentation
The Turnkey Solution
ISHA’S GMP Consultancy provided end-to-end project management, including facility design, vendor qualification, cleanroom engineering, validation protocols, and regulatory readiness support. (ISHA’S GMP TURNKEY CONSULTANCY EUROPE LIMITED)
Impact & Outcomes
35,000 sq. ft. WHO-GMP compliant facility delivered
Project completed within 14 months
Successful regulatory inspections
Manufacturing operations commenced as planned (ISHA'S GMP TURNKEY CONSULTANCY EUROPE LIMITED)