Equipment and Facilities

GMP requires that all equipment used in manufacturing is qualified before use and maintained in a qualified state throughout its operational life. The qualification lifecycle has four stages: Design Qualification (DQ) — documenting that the proposed design meets the user's requirements; Installation Qualification (IQ) — verifying that the equipment is installed correctly per the manufacturer's specification; Operational Qualification (OQ) — demonstrating that it operates within defined parameters under all anticipated conditions; and Performance Qualification (PQ) — confirming it consistently performs as intended under real production conditions. No equipment should be used in GMP manufacturing until IQ and OQ (at minimum) are complete, and PQ is required before routine batch production.

Calibration ensures that measurement instruments — balances, thermometers, pressure gauges, flow meters — are accurate and traceable to national or international standards. GMP requires calibration programmes with defined intervals, and any instrument found to be out of calibration must trigger a formal investigation: all results obtained with that instrument since its last successful calibration are potentially compromised and must be assessed. Change control is the formal process through which any modification to qualified equipment, facilities, utilities, or systems is assessed, approved, documented, and re-qualified before the change is implemented in production. It exists to ensure that changes do not inadvertently introduce new risks.

GMP facility design follows several key principles: segregation of operations to prevent mix-up and cross-contamination (separate areas for different products, different stages, quarantine versus released materials); unidirectional material and personnel flows to reduce contamination risk; surfaces (floors, walls, ceilings) that are smooth, impermeable, and cleanable; adequate drainage without backflow risk; and qualified utilities including Purified Water, Water for Injection, compressed air, and clean steam, each of which has its own specification and monitoring programme.