Equipment Qualification (EQ) for tablet manufacturing is the documented evidence that each piece of equipment is correctly designed, installed, operates as intended, and consistently performs within defined limits to produce quality tablets. It forms a core part of GMP compliance and supports process validation.
EQ typically follows a life-cycle approach:
1) User Requirement Specification (URS): Defines what the equipment must do (capacity, speed range, materials of construction, contamination control, data integrity needs, cleaning method, safety interlocks, utilities). For tablets, URS is critical for equipment like blender, granulator, fluid bed dryer, mill, compression machine, deduster, and metal detector.
2) Design Qualification (DQ): Confirms the proposed design meets URS and GMP (e.g., contact parts SS316L, dust extraction, closed transfer, filters, instrumentation accuracy, calibration access, and software controls).
3) Installation Qualification (IQ): Verifies correct installation as per drawings and manuals: utilities (power, compressed air, vacuum), equipment tags, material certificates, lubrication plans, wiring, alarms, interlocks, spare parts list, and calibration status of sensors (RPM, temperature, pressure, load cells).
4) Operational Qualification (OQ): Demonstrates the equipment operates across defined ranges. For tablet compression, OQ includes turret speed limits, feeder speed, pre-compression/main compression force control, weight control system challenge tests, ejection force, alarms, and safety guards. For dryers, it includes airflow/temperature mapping and control performance.
5) Performance Qualification (PQ): Confirms consistent performance under routine conditions with product or placebo. For compression, PQ checks tablet weight variation, hardness, thickness, friability, disintegration, content uniformity (as applicable), and rejects handling over multiple runs.
Supporting elements: SOPs, preventive maintenance, cleaning validation linkage, change control, training, and periodic review/re-qualification (especially after major repairs, relocation, software changes, or utility modifications). Strong EQ ensures reproducible tablets, reduces deviations, and protects patient safety.