1. Equipment Design & Installation

• Equipment designed with GMP-compliant sanitary design (easy to clean, non-reactive materials).

• Materials of construction suitable (e.g., SS 316L for product contact).

• Installation Qualification (IQ) completed and documented.

• Equipment layout prevents mix-ups and cross-contamination.

• Equipment identified with unique ID numbers.

2. Qualification & Validation

• IQ/OQ/PQ completed and approved before use.

• Performance qualification reflects actual operating conditions.

• Cleaning and sterilization validation performed (if applicable).

• Requalification/revalidation done after modifications or repairs.

3. Calibration & Preventive Maintenance

• Calibration program established with defined frequency.

• Calibration status displayed (Calibrated / Due / Out of Service).

• Calibration traceable to national/international standards.

• Preventive maintenance performed as per schedule and records available.

• Spare parts and maintenance logs documented.

4. Cleaning & Sanitation

• Equipment cleaned as per approved SOPs.

• Cleaning records/logbooks maintained and reviewed.

• “Cleaned / In Use / To Be Cleaned” status labels displayed.

• Cleaning validation performed for product-contact equipment.

• Dedicated/differentiated equipment used for high-risk products (e.g., penicillin, hormones, cytotoxics).

5. Operation & Safety

• SOPs available for operation, cleaning, and maintenance.

• Operators trained and qualified to use the equipment.

• Equipment guards, emergency stops, and alarms functional.

• Safety interlocks tested and verified.

• Lubricants and coolants used are food/pharma grade.

6. Documentation

• Equipment logbooks maintained (usage, cleaning, maintenance, calibration).

• Entries made contemporaneously and in compliance with ALCOA+ principles.

• Deviations and breakdowns documented and investigated.

• Change control followed for modifications in equipment.

• Data integrity ensured in computerized equipment systems.

7. Utilities Integration

• Utility connections (water, compressed air, vacuum, steam, nitrogen) qualified.

• Pressure, temperature, and flow controls functioning and recorded.

• HEPA filters/air handling systems validated (for cleanroom equipment).

8. Compliance & Audit Readiness

• Equipment complies with USFDA, EMA, WHO, and GMP expectations.

• Certificates of compliance/traceability available for critical components.

• Electronic systems (SCADA, PLC) validated (CSV – Computer System Validation).

• Audit trails enabled and reviewed regularly.

✅ Key Audit Focus Points:

• Proper status labeling of equipment.

• Traceability in calibration/maintenance records.

• Effectiveness of cleaning validation.

• Observation of operator practices (real-time compliance).

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