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