Pharmaceutical Projects
Projects Life-Cycle
A pharmaceutical turnkey project - from concept to commissioning -delivered as a "ready-to-run" solution. Here's a step-by-step outline of the typical process:
🔹 1. Project Planning & Feasibility
Market analysis & demand forecasting
Budget estimation
Project timeline planning
Site selection and evaluation
🔹 2. Regulatory & Compliance
Adherence to GMP, FDA, EU, WHO, or local regulations
Environmental and safety compliance
Water Reports
validation master plan, DQ/IQ/OQ/PQ protocols
🔹 3. Conceptual & Detailed Design
Facility layout & cleanroom classification (A per FDA guidelines)
HVAC system planning (airflow, pressure differentials)
Utility planning (WFI, PW, HVAC, electricals, gases)
Workflow optimization: personnel, materials, product.
🔹 4. Engineering & Civil Construction
Soil Testing & Structural Design
Structural Design
Architect's Impression.
Wind and load analysis
Waterproofing and drainage details
Integration of HVAC and service ducts if needed
Safety systems (Evacuation, fire resistance, smoke vents)
Civil works (flooring, walls, ceiling, drainage)
HVAC installation
Electrical and plumbing works
Cleanroom paneling and infrastructure.
🔹 5. Equipment Supply & Installation
Procurement of production machinery
Procurement of Packaging machinery
Procurement of Testing Lab Equipment
Utilities (WFI, steam, air compressors)
Procurement of Accessaries
Installation and alignment of machines
🔹 6. Validation & Qualification
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Cleanroom validation, HVAC validation.
🔹 7. Documentation & SOPs
Preparation of:
Batch Manufacturing Records (BMR)
SOPs for equipment and facility
Calibration & maintenance logs
Quality manuals and GMP documentation.
🔹 8. HR & Training
Hire Staff & train on:
Administration
Accounts & Purchase
Production & manufacturing (FDA Approved)
Packaging
Equipment operation
GMP compliance
Safety protocols
SOP adherence
Engineering maintenance
QC, QA (FDA Approved)
Documentation
IT
Stores
Sales & Markeing
🔹 9. Trial Production & Test Batches
Trial runs for each process
In-process and finished product testing
Regulatory audits (if needed)
🔹 10. Final Handover & Support
Full documentation handover
Regulatory compliance checklist
Optional post-handover support (Plant Operation for some period, AMC, maintenance, training, expansion etc.)
Strictly followed local FDA guidelines and documentations required for IV fluids, Serum, parenterals and ophthalmic products to ensure successful project execution and compliance.
GMP
Engineering Better BFS Performance
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