as of 2018 - 12 - 03
18.E Self-inspection
18.E.1 Introduction
18.E.2 Objectives of self-inspections
18.E.3 Inspection areas
18.E.4 Frequency of self-inspections
18.E.5 Requirements for inspectors
18.E.6 Self-inspection process
18.E.6.1 Planning
18.E.6.2 Implementation
18.E.6.3 Wrap-up
18.E.6.4 Follow-up
18.E.7 Documentation
18.E.7.1 Sample report for self-inspections
18.E.8 Evaluation
18.E.8.1 Sample calculation for determining the GMP compliance of a quality management system
18.E.9 Periodic evaluation of the self-inspection system
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