Data Metrics and Current Inspection Trends Jenny Hantzinikolas - - PowerPoint PPT Presentation

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Data Metrics and Current Inspection Trends Jenny Hantzinikolas - - PowerPoint PPT Presentation

Dec 13, 2022 458 likes •652 views

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

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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

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Overview

  • Close out process
  • Performance metrics and outcome
  • Inspection compliance outcomes
  • Managing the risk
  • Monitoring compliance
  • Common deficiencies

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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.

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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.

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Performance metrics

16/17 Financial Year

95.43% 95.12% 78% 80% 82% 84% 86% 88% 90% 92% 94% 96% 98% GMP Clearances using Overseas Approvals Inspections Closed Out within Target Timeframes

Source: data extracted 1 November 2016

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Domestic inspection outcomes

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% In Progress 0.46% 0.00% 1.02% 1.34% 4.73% 11.82% 0% 10% 20% 30% 40% 50% 60%

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Overseas inspection outcomes

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% In Progress 0.00% 0.00% 0.00% 2.00% 0.00% 16.42% 0% 10% 20% 30% 40% 50% 60% 70%

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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

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Managing the risks – registered medicines and blood, tissues and cellular therapies

Risk rating Third and subsequent consecutive A1 Second consecutive A1 First A1 A2 A3 H 36 + reduced scope inspection 36 24 18 12 M 36 + reduced scope inspection 36 30 20 15 L 36 + reduced scope inspection 36 + reduced scope inspection 36 24 18

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Managing the risks – listed medicines

Risk rating Third and subsequent consecutive A1 Second consecutive A1 First A1 A2 A3 L 48 + reduced scope inspection 48 42 30 18 Other

  • Reinspection only if risk information or complaint
  • Biennial compliance review (desk top)

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Monitoring and ensuring compliance

“A full suite of regulatory tools is appropriately utilised to ensure compliance.”

Data Metrics and Current Inspection Trends

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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

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Current inspection trends

Most common types of deficiencies in 2016 related to

  • Poor investigations
  • Automated systems
  • Validation
  • Procedures
  • Quality control

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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

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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

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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

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Summary

  • More than 85% inspections are closed out on time
  • The inspection compliance rating trends for 2016 for both
  • verseas 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.

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Questions

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