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.

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