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Facility Preparedness
Facility exterior and grounds are well-maintained
Facility entry and access points are controlled
Facility layout and flow are organized
Facility lighting, ventilation, and temperature are suitable
Documentation and Records
Standard operating procedures (SOPs) are up-to-date
Training records are complete and organized
Deviation and investigation reports are thorough
Batch records are accurate and readily available
Quality Systems
Quality control testing is performed as scheduled
Product quality reviews are conducted regularly
Complaints and recalls are handled efficiently
Corrective and preventive actions (CAPAs) are effective
Personnel and Training
All personnel are properly trained and qualified
Personnel hygiene and attire are appropriate
Personnel access and responsibilities are clearly defined
Continuous training program is in place
Materials and Inventory
Raw materials are tested and approved prior to use
Inventory control and material storage are adequate
Quarantine and disposition of non-conforming materials
Supplier qualification and evaluation program is in place
Equipment and Utilities
Equipment is properly maintained and calibrated
Utilities (water, air, power) are suitable and monitored
Cleaning and sanitization procedures are effective
Computerized systems are validated and secure
