Client
Existing Pharmaceutical Manufacturing Facility
Challenge
The client needed comprehensive qualification and validation support to prepare for regulatory inspections.
Scope of Work Execution
Validation Master Plan
DQ, IQ, OQ, PQ protocols
HVAC qualification
Water system qualification
Equipment qualification
Cleaning validation
Solutions
ISHA’S GMP TURNKEY CONSULTANCY EUROPE LIMITED deployed validation specialists to execute qualification activities and prepare GMP-compliant reports and SOPs.
Impact & Outcomes
Complete validation lifecycle executed
Improved audit preparedness
Strengthened quality systems
Regulatory compliance maintained