GMP-Compliant API Manufacturing Plant Setup
Project Desciption
A leading API manufacturer required a new GMP-compliant production facility designed according to US-FDA, EU-GMP, WHO-GMP, and Schedule M guidelines.
The objective was to build a regulatory-ready, efficient, and safe production block including key areas such as dispensing, reaction, filtration, drying, utilities, QC, and support infrastructure.
The client required complete plant consultancy, integrating process flow, utilities, safety systems, documentation, HVAC, and validation support.
⭐ PROJECT PROCESS / APPROACH
1️⃣ Requirement Understanding & Site Study
- Detailed discussion with production, QA, utilities & EHS teams
- Study of the existing facility layout, space constraints & material flow
- Collection of process information, equipment list & utility parameters
2️⃣ Concept Development & Layout Design
- Conceptual layouts as per GMP flow principles
- Personnel & material movement planning
- Dirty → Clean → Sterile segregation
- Pressure cascade & zone classification
- Utility room, scrubber, boiler & AHU placement optimization
3️⃣ GMP Compliance & Documentation Framework
- Regulatory compliance mapping (US-FDA, EMA, WHO)
- Preparation of URS, DDS & GMP design basis
- Identification of CCPs, risk assessment & mitigation planning
4️⃣ Utility Engineering & System Design
- Complete utility load estimation
- P&IDs for:
- Steam & condensate
- Chilled water & brine
- Compressed air
- Vacuum
- Cooling water
- Nitrogen
- Equipment selection guidelines & sizing
5️⃣ HVAC, Cleanroom & Airflow Engineering
- HVAC zoning & pressure hierarchy
- Fresh air, return air & exhaust balancing
- HEPA filtration & room classification
- AHU selection & ducting layout
6️⃣ Process Safety & Automation Integration
- Safety interlocks for reactors, pumps, utilities
- Explosion-proof/ATEX considerations
- PLC-based monitoring recommendations
- Critical alarm & trip logics
7️⃣ Construction-Level Drawings & Execution Support
- Detailed 2D/3D engineering
- Isometrics, section drawings, and equipment GA
- Structural support drawings
- Vendor coordination & technical supervision
8️⃣ Validation & Handover Support
- IQ/OQ support documentation
- As-built drawings
- Equipment tagging & calibration guidelines
- Final GMP compliance checklist
⭐ WORK SCOPE (Full List)
⭐ WORK SCOPE
- ✔ Facility Layout & Space Planning
- ✔ Utility & Mechanical Engineering
- ✔ HVAC & Cleanroom Engineering
- ✔ Regulatory Compliance & Documentation
- ✔ Piping & Isometric Drawings
- ✔ Safety & Automation Recommendations
- ✔ Supervision & Vendor Coordination
- ✔ Validation (IQ/OQ) Preparation
