Facility Qualification ensures that pharmaceutical manufacturing areas are designed, constructed, and operated in a manner that meets GMP expectations for cleanliness, environmental control, personnel/material flow, and contamination prevention. PrimeGMP performs end-to-end qualification of sterile and non-sterile facilities to ensure compliance with global regulatory requirements and readiness for audits and inspections.

1. Design Qualification (DQ)

• Review of URS, layout drawings, zoning strategy, and room classification
• Verification of personnel/material flow, segregation, and contamination control strategy
• Evaluation of HVAC zoning, pressure cascades, AHU mapping
• Review of surface finishes, covings, doors, pass boxes, drains, and cleanroom construction
• Assessment of utilities: pure steam, PW/WFI, nitrogen, compressed air
• Compliance with EU GMP Annex 1, WHO TRS, USFDA, ISO 14644, ICH Q9

2. Installation Qualification (IQ)

• Inspection of rooms, finishes, covings, door interlocks, floors, and cleanroom fittings
• Verification of AHU/ducting installation, HEPAs, air terminals, pressure gauges
• Room classification signage, sampling ports, electrical & utility connections
• Review of construction material certificates and vendor documentation
• Calibration check of differential pressure gauges, sensors, temperature/RH instruments
• Verification of as-built conditions vs design drawings

3. Operational Qualification (OQ)

• Differential pressure verification across zoning hierarchy
• Airflow measurements & ACPH verification
• HEPA filter integrity testing (DOP/PAO)
• Room recovery time tests
• Temperature & humidity distribution
• Lux level measurement
• Airflow visualization (Smoke Study)
• Room pressurization, cascade & door interlock functionality
• Environmental monitoring at-rest baseline (non-viable & viable)
• Verification of utilities (PW/WFI, pure steam, compressed air, nitrogen)

4. Performance Qualification (PQ)

• Dynamic environmental monitoring: viable, non-viable, settle plates, contact plates
• Simulation of typical personnel movement & equipment operation
• PQ of HEPA and airflow performance under working conditions
• Microbial control verification in critical & background areas
• PQ of cleaning & disinfection procedures
• PQ of pressure/airflow stability during operations
• Verification of gowning procedures, personnel flow & behavioral compliance
• Trending of Temp/RH, DP, ACPH during actual operations

Facility Elements Covered

• Cleanrooms (ISO 5, 7, 8; Grade A/B/C/D)
• Sterile & aseptic manufacturing suites
• Dry powder injection facilities
• OSD production blocks
• QC laboratories
• Warehouses, cold rooms & quarantine areas
• CNC/CNA classified zones
• BMR/BPR rooms, dispensing & sampling rooms
• Material/personnel airlocks, pass boxes

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• HVAC qualification integration reports
• Smoke study video & photo evidence
• Room classification maps & trending charts
• Environmental monitoring reports (at-rest & dynamic)
• Cleaning validation alignment documents
• Calibration records & certificates
• Change control/corrections & CAPA recommendations
• Final Facility Qualification Report

Regulatory Standards Followed

• EU GMP Annex 1 (Aseptic Manufacturing)
• EU GMP Annex 15 (Qualification & Validation)
• WHO TRS 961 / 1019
• ISO 14644 (Cleanrooms & Controlled Environments)
• USFDA 21 CFR 210/211
• ISPE Baseline Guides

Why Choose PrimeGMP for Facility Qualification?

• Strong sterile & non-sterile facility expertise
• Complete HVAC + Utility + EM integration
• High-quality video documentation for smoke studies
• Audit-ready reports with clear CAPA recommendations
• Experienced team to handle complex facility layouts
• Regulatory-focused approach tailored to your operations