Designing and building a GMP (Good Manufacturing Practices) facility involves a structured, multi-phase process focused on preventing contamination, ensuring product quality, and meeting strict regulatory standards (FDA, EMA, etc.) by integrating unidirectional workflows, segregated zones, controlled environments (HVAC, HEPA), seamless surfaces, and robust validation (IQ/OQ/PQ) from concept to commissioning. Key elements include early collaboration, detailed user requirement briefs, process flow mapping, specialized cleanroom construction, environmental control, and rigorous documentation to “build-in” quality.
Overview services:
VBC provide advisory consultation for
- Concept & Planning (User Requirements): Define scope, processes, regulatory needs (URB/FRB), workflow, and potential future scalability.
- Detailed Design & Engineering: Create layouts with unidirectional flow, segregated areas (weighing, processing, packing), airlocks, pressure cascades, and integrated HVAC systems.
- Construction & Installation: Build cleanrooms, install seamless finishes (cove corners), and integrate equipment, ensuring easy cleaning and maintenance.
- Commissioning & Validation (IQ/OQ/PQ): Qualify equipment (Installation Qualification), processes (Operational Qualification), and final product performance (Performance Qualification) to prove GMP readiness.
- Documentation: Develop a Validation Master Plan (VMP) and maintain meticulous records.
- Automation: Integrates PLCs, SCADA/HMIs, and batch software for reproducibility, reduced human error, and easier audits/training.
- cGMP Quality Management Systems and Audit
Request for service
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