A comprehensive audit checklist for evaluating GMP compliance in pharmaceutical change control and deviation management processes, ensuring systematic control of changes and effective handling of deviations.
GMP Change Control and Deviation Management Audit Checklist
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About This Checklist
Effective change control and deviation management are critical components of maintaining GMP compliance in the pharmaceutical industry. This GMP Change Control and Deviation Management Audit Checklist is an indispensable tool for evaluating the robustness of processes that manage changes and address deviations in pharmaceutical manufacturing. It focuses on ensuring that all modifications to facilities, equipment, processes, and documentation are properly assessed, approved, and implemented, while also verifying that deviations from standard procedures are adequately investigated and resolved. By systematically reviewing these areas, pharmaceutical companies can maintain product quality, ensure regulatory compliance, and drive continuous improvement in their operations.
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Ensures comprehensive evaluation of change control and deviation management processes
Helps prevent unintended consequences of changes in manufacturing processes
Supports compliance with GMP requirements for change management and deviation handling
Enhances product quality and consistency through systematic control of changes
Facilitates continuous improvement and risk management in pharmaceutical operations
