GMP Self-Inspection and Internal Audit Checklist

Program and Planning

Establish the self-inspection system.

• Is there an approved self-inspection procedure defining scope, frequency, and responsibilities? *
• Is a risk-based annual self-inspection schedule covering all GMP areas and quality systems? *
• Are for-cause or follow-up inspections triggered by significant events or trends?

Auditor Independence and Competence

• Are self-inspections conducted by competent, trained auditors independent of the area being inspected? *
• Are external experts used where additional independence or expertise is required?
• Is auditor training and qualification documented? *

Conduct and Findings

• Are inspections conducted against defined criteria (regulations, procedures, prior findings)? *
• Are findings documented, risk-classified (e.g., critical, major, minor), and reported to management? *
• Are observations recorded objectively with supporting evidence? *

CAPA and Effectiveness

• Are corrective and preventive actions assigned with owners and due dates for each finding? *
• Is CAPA completion and effectiveness verified and tracked to closure? *
• Are self-inspection results and trends reviewed in management review? *