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Description - Figure 1.0 - Summary Report: Stakeholder Consultations on the Good Manufacturing Practices (GMP) Inspection Program Review

Figure 1.0 Support for various proposed risk criteria

Bar chart showing total number of stakeholders supportive of each proposed risk criterion

Activities performed = 20 stakeholders; Product range and complexity = 11 stakeholders; Complexity and criticality of processes = 16 stakeholders; General Good Manufacturing Practices compliance history = 34 stakeholders; Recent changes at company = 7 stakeholders; Sole or limited source = 3 stakeholders; Concerns raised by public or other regulatory authorities = 11 stakeholders; Other enforcement measures taken, lack of co-operation = 7 stakeholders; Significant concern over robustness of quality system = 12 stakeholders; Significant nature of future changes on site = 0 stakeholders; Significant failures to complete actions to close previous deficiencies = 15 stakeholders; Site-based recalls since last inspection = 10 stakeholders; Regulatory actions taken, lack of co-operation = 6 stakeholders.