GMP Audit Checklist – Personnel & Premises

1. Personnel

1.1 Organization & Staffing

• Adequate number of trained and qualified staff available.

• Organizational chart available and updated.

• Clear roles, responsibilities, and reporting lines defined.

1.2 Training

• Initial and periodic GMP training provided to all staff.

• Training records complete, signed, and up to date.

• Effectiveness of training evaluated and documented.

• Job-specific and safety training conducted (e.g., aseptic practices, equipment handling).

1.3 Gowning & Hygiene

• Gowning procedure defined and followed as per area classification.

• Personal hygiene standards maintained (handwashing, no jewelry, trimmed nails).

• Gowning records/logbooks maintained.

• Adequate gowning material availability and laundering system validated.

• Health checks (pre-employment and periodic medical fitness) performed.

1.4 Conduct in GMP Areas

• Access restricted to authorized personnel only.

• Eating, drinking, smoking, and personal items prohibited in production/QC areas.

• Personnel movement controlled to prevent contamination.

• Visitors/contractors trained and accompanied during entry.

2. Premises

2.1 Facility Design & Layout

• Facility designed for unidirectional flow of men and materials.

• Segregation of critical areas (dispensing, manufacturing, packaging, QC, warehouse).

• Adequate space to prevent mix-ups and cross-contamination.

• Walls, floors, and ceilings smooth, washable, and damage-free.

2.2 Environmental Controls

• Temperature, humidity, and differential pressure monitored and recorded.

• Air Handling Units (AHUs) qualified and maintained.

• HEPA filters integrity-tested as per schedule.

• Cleanroom classification validated and monitored.

• Pest control program implemented with records.

2.3 Cleaning & Housekeeping

• SOPs available for cleaning of premises.

• Cleaning records/logbooks completed and reviewed.

• Dedicated cleaning equipment identified and maintained.

• No accumulation of waste, dust, or unused materials.

2.4 Utilities

• Water system (Purified Water/WFI) validated and monitored.

• Compressed air, steam, and gases qualified and tested.

• Electrical systems, lighting, and emergency power supply maintained.

• Drainage system designed to prevent backflow and contamination.

2.5 Safety & Compliance

• Firefighting equipment and alarms installed and tested.

• Emergency exits unobstructed and marked.

• Restricted areas labeled properly.

• Material safety data sheets (MSDS) available in relevant areas.

✅ Key Points for Auditors:

• Check for ALCOA+ compliance in records.

• Observe staff practices during audit (gowning, hygiene, documentation).

• Physically verify cleanliness and maintenance of premises.

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