FACILITY QUALIFICATION IN PHARMA

1. Facility Qualification Protocol
2. DQ Facility Qualification Protocol
3. RM Store Airlock
4. Packing Hall
5. PM Day Store
6. Change room 3rd
7. Change room 2nd
8. Change room Ist
9. Dress wash area
10. Equipment wash area
11. Tool room
12. IPQA Room
13. RM Day store area
14. Dry powder injection filling area
15. Autoclave Loading side
16. Dispensing Room
17. Blister packing area
18. Bottle decartoning area
19. Garment wash area
20. Tunnel area
21. Clean Equipment area
22. Tablet coating area
23. Blend store area
24. Capsule filling area
25. Dirty equipment washing area
26. Dry syrup filling & sealing area
27. Filled capsule & tablet store area
28. Granulation area
29. Strip packing area
30. Tablet Compression area

Facility qualification in pharma is a systematic process of verifying and documenting that the design, construction, and operation of a pharmaceutical facility meet GMP requirements and ensure product quality and patient safety.

1. Purpose of Facility Qualification

• Demonstrate compliance with GMP and regulatory standards (FDA, EMA, WHO, etc.).
• Provide documented evidence the facility:
  • Is fit for its intended purpose.
  • Consistently operates within defined parameters.
  • Supports production of safe and effective medicines.

2. Phases of Facility Qualification

Facility Qualification is part of the Validation Lifecycle, typically following this sequence:

Phase	Description
URS (User Requirements Specification)	What the facility must be able to do.
DQ (Design Qualification)	Verify the design meets requirements.
IQ (Installation Qualification)	Verify installation against approved design/specs.
OQ (Operational Qualification)	Verify operation within defined parameters.
PQ (Performance Qualification)	Confirm performance under routine conditions.

User Requirements Specification (URS)

• Foundation document stating functional, regulatory, and process requirements.
• Includes:
  • Classification of areas (e.g., ISO 7, Grade C)
  • HVAC specifications
  • Utilities requirements (WFI, compressed air)
  • Equipment capacity and compatibility

Design Qualification (DQ)

• Documented verification that design:
  • Meets URS and GMP.
  • Includes material selection, cleanroom layouts, utility flows.
• Review design documents:
  • Layout drawings
  • HVAC schematics
  • Containment measures
  • Utility distribution

Installation Qualification (IQ)

• Verify and document installation as per approved design and manufacturer recommendations:
  • Facility finishes
  • Cleanroom construction materials
  • HVAC and HEPA filter installation
  • Utilities (water, gases, power)
• Includes:
  • Equipment tagging and calibration records
  • Verification of critical components
  • As-built drawings
  • Certificates of materials and compliance

Operational Qualification (OQ)

• Confirm the facility operates within specified ranges:
  • HVAC airflow patterns, pressure differentials, temperature, and RH.
  • Access controls, alarms, and interlocks.
  • Environmental monitoring system functionality.
• Includes:
  • Room recovery tests
  • Air change rate verification
  • HEPA filter integrity (leak tests)
  • Alarm/alert system verification

Performance Qualification (PQ)

• Verify the facility supports actual production consistently:
  • Environmental monitoring during simulated operations.
  • Media fills (for aseptic areas).
  • Cleaning and sanitization effectiveness.
• Typically involves:
  • Dynamic monitoring with personnel present.
  • Confirming microbial and particulate control.

3. Key Deliverables

Qualification Protocols & Reports for each phase (IQ/OQ/PQ).
Traceability Matrix linking URS requirements to verification.
Deviation Reports and Resolutions.
Calibration and Maintenance Schedules.
Change Control Records if modifications occur.

4. Regulatory Expectations

Guidelines to reference:

• EU GMP Annex 15 (Qualification and Validation)
• WHO Technical Report Series No. 1019
• FDA Guidance for Industry: Process Validation
• ISPE Baseline Guides (e.g., Vol. 5: Commissioning & Qualification)

5. Best Practices

• Involve multidisciplinary teams (Engineering, QA, Validation, Production).
• Use risk-based approach—focus on critical aspects affecting product quality.
• Pre-approve and strictly follow protocols.
• Document deviations and CAPA.
• Maintain qualified state through ongoing maintenance, calibration, and requalification.

6. Maintaining Qualified State

After initial qualification:

• Periodic Requalification: e.g., HVAC HEPA filters annually.
• Change Control: Evaluate impact of modifications.
• Environmental Monitoring: Confirm continued compliance.
• Preventive Maintenance: Keep facility and utilities in a validated state.