Data Metrics and Current Inspection Trends Jenny Hantzinikolas Director, Inspections, Manufacturing Quality Branch Medical Devices and Product Quality Division, TGA International Regulatory Convergence for MTP GMP
Overview • Close out process • Performance metrics and outcome • Inspection compliance outcomes • Managing the risk • Monitoring compliance • Common deficiencies 2 Data Metrics and Current Inspection Trends
Current inspection trends New close out process • Issue post-inspection letter. • Responses received on a close out template with a CAPA plan. • Up to 3 responses then escalate to an internal review process. 3 Data Metrics and Current Inspection Trends
Current inspection trends New close out process • Objective evidence requested only under certain situations e.g. initial, recurring issues • Final inspection report sent once the inspection responses are completed • Addition of time at the next inspection for A2 and A3 manufacturers to review the evidence from the CAPA PLAN. 4 Data Metrics and Current Inspection Trends
Performance metrics 16/17 Financial Year 98% 95.43% 95.12% 96% 94% 92% 90% 88% 86% 84% 82% 80% 78% GMP Clearances using Overseas Approvals Inspections Closed Out within Target Timeframes Source: data extracted 1 November 2016 5
Domestic inspection outcomes 60% 50% 40% 30% 20% 10% 0% FY 10/11 FY 11/12 FY 12/13 FY 13/14 FY 14/15 FY 15/16 A1 35.33% 30.84% 28.42% 32.22% 51.49% 33.00% A2 41.28% 47.76% 55.33% 52.35% 35.50% 38.92% A3 21.10% 16.92% 13.20% 14.09% 7.69% 15.27% U 1.83% 4.48% 2.03% 0.00% 0.59% 0.99% 6 In Progress 0.46% 0.00% 1.02% 1.34% 4.73% 11.82%
Overseas inspection outcomes 70% 60% 50% 40% 30% 20% 10% 0% FY 10/11 FY 11/12 FY 12/13 FY 13/14 FY 14/15 FY 15/16 A1 30.92% 26.77% 42.71% 46.00% 42.86% 53.73% A2 46.71% 61.42% 44.79% 46.00% 47.62% 25.37% A3 18.42% 9.45% 11.46% 6.00% 8.57% 2.99% U 3.95% 2.36% 1.04% 0.00% 0.95% 1.49% 7 In Progress 0.00% 0.00% 0.00% 2.00% 0.00% 16.42%
Managing manufacturing quality risks “ Where the risk of non-compliance is high or the consequence of non- compliance signficant, there is a higher degree of monitoring .” Data Metrics and Current Inspection Trends
Managing the risks – registered medicines and blood, tissues and cellular therapies Risk Third and subsequent Second consecutive A1 First A1 A2 A3 rating consecutive A1 H 36 + reduced scope 36 24 18 12 inspection M 36 + reduced scope 36 30 20 15 inspection L 36 + reduced scope 36 + reduced scope 36 24 18 inspection inspection 9 Data Metrics and Current Inspection Trends
Managing the risks – listed medicines Risk Third and subsequent Second consecutive A1 First A1 A2 A3 rating consecutive A1 L 48 + reduced scope 48 42 30 18 inspection Other • Reinspection only if risk information or complaint • Biennial compliance review (desk top) 10 Data Metrics and Current Inspection Trends
Monitoring and ensuring compliance “A full suite of regulatory tools is appropriately utilised to ensure compliance.” Data Metrics and Current Inspection Trends
Monitoring and compliance tools • Collaboration with international regulators • Manufacturing quality signal detection • Unannounced inspections • Bring planned inspections forward • Condition, cancel, suspend GMP licence • Cancel GMP clearances 12 Data Metrics and Current Inspection Trends
Current inspection trends Most common types of deficiencies in 2016 related to • Poor investigations • Automated systems • Validation • Procedures • Quality control 13 Data Metrics and Current Inspection Trends
Common deficiencies for sterile manufacturers 2016 – Domestic manufacturers Poor procedures Quality Risk management Microbial contamination Environmental monitoring Automated systems Potential for cross contamination Poor records Training Validation Cleaning 14 Data Metrics and Current Inspection Trends
Common deficiencies for sterile manufacturers 2016 – Overseas manufacturers Poor procedures Quality risk management Inadequate Investigations Environmental monitoring Automated systems Change control Poor records Microbial contamination Validation Training 15 Data Metrics and Current Inspection Trends
Common deficiencies for API manufacturers 2016 – Both domestic and overseas manufacturers Poor procedures Records Inadequate Investigations Process Validation Training Automated Systems Cleaning validation Potential for cross contamination Annual product review Batch records 16 Data Metrics and Current Inspection Trends
Summary • More than 85% inspections are closed out on time • The inspection compliance rating trends for 2016 for both overseas and domestic manufacturers were provided • The types of deficiencies observed have been provided for 2016 for all types of manufacturers, sterile manufacturers and API manufacturers. 17 Data Metrics and Current Inspection Trends
Questions 18 Data Metrics and Current Inspection Trends
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