Client
API and Fine Chemicals Manufacturer
Challenge
Expansion of API production capacity while maintaining GMP compliance and process containment.
Scope of Work Execution
Process block layout
Utility system design
Equipment qualification
Environmental and containment planning
GMP documentation
Solutions
ISHA’S GMP Consultancy developed engineering designs, process flow optimization, and validation strategies for API production operations.
Impact & Outcomes
Increased manufacturing capacity
Improved regulatory compliance
Reduced cross-contamination risk
Enhanced operational productivity