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Presentation: Current inspection trends

TGA presentations: ARCS Scientific Congress Canberra, 10-11 August 2016

15 August 2016

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Presentation

  • Presented by: Jenny Hantzinikolas
  • Presented at: The ARCS Scientific Congress
  • Presentation date: 10-11 August 2016
  • Presentation summary: This presentation will focus on the common types of deficiencies found by the TGA's GMP Inspectors as well as some data on the number of inspections performed both locally and overseas and compliance rating outcomes for the inspections performed.

Transcript

Current inspection trends

Jenny Hantzinikolas
Director, Inspections Section
Manufacturing Quality Branch
Medical Device and Product Quality Division, TGA

ARCS Scientific Congress 2016, 10-11 August 2016

Slide 1 - Presentation overview

  • TGA Portfolio Budget Statement performance
  • Outcome of Inspections
  • 2016 Inspections trends
  • 2015 Inspection trends
  • Close out process

Slide 2 - Portfolio Budget Statement

  • KPI- Inspections closed out within target timeframes
  • The target is 85%

Slide 3 - Portfolio Budget Statement - 15/16 financial year

GMP Clearances using overseas approvals - 95.05%; Inspections closed out within target timeframes - 87.35%

Portfolio Budget Statement for the 15/16 financial year. GMP Clearances using Overseas Approvals is at 95.05% and Inspections Closed Out within Target Timeframes is at 87.35%.

Slide 4 - Current inspection trends

Most common types of deficiencies in 2016 to date related to

  • Poor investigations
  • Computerised systems
  • Validation
  • QMS
  • Quality control

Slide 5 - 2015 Overseas inspections: Top 10 most occurring deficiencies

graph

  1. Documentation - Quality systems elements/procedures
  2. Quality risk management
    • Calibration of measuring and test equipment
    • In-process control and monitoring of production operations
  3. Equipment storage - contamination (potential)
  4. Complaints and product recall
    • Investigation of anomalies
    • Documentation - manufacturing
    • Equipment validation
  5. Product quality review
    • Change control
    • Personnel issues - training
    • Sampling procedures and facilities
    • Starting material and packaging component testing
    • Design and maintenance of premises
    • Status labelling - work in progress, facilities and equipment
    • Batch release procedures
    • Analytical validation

Slide 6 - 2015 Overseas inspections: Top 5 major only deficiencies

graph

  1. Analytical validation
  2. Cleaning validation
    • Quality risk management
    • In-process control and monitoring of production operations
    • Process validation
    • Documentation - quality systems elements/procedures
    • Batch release procedures
    • Computerised systems - documentation and control
    • Validation master plan and documentation
    • Equipment validation
    • Product quality review
    • Sampling procedures and facilities
    • Starting material and packaging component testing
    • Documentation - specifications and testing
    • Supplier and contractor technical agreements
    • Supplier and contractor audit
    • Investigation of anomalies - out-of-specification
    • Sterility assurance

Slide 7 - 2015 Domestic inspections: Top 10 most occurring deficiencies

graph

  1. Management and control of misc records
  2. Documentation - quality systems elements/procedures
  3. Personnel issues - training
  4. Complaints and product recall
  5. Change control
  6. Investigation of anomalies
  7. Quality risk management
    • Equipment validation
    • Product quality review
    • Calibration of measuring and test equipment
    • Validation master plan and documentation
    • Personnel issues - duties of key personnel
  8. Supplier and contractor technical agreements

Slide 8 - 2015 Domestic inspections: Top 5 major only deficiencies

graph

  1. Batch release procedures
    • Change control
    • Process validation
    • Investigation of anomalies
    • Sterility assurance
    • Finished product testing - on-going stability
    • Analytical validation
    • Personnel issues - training
    • Validation master plan and documentation
    • Equipment validation
    • Cleaning validation

Slide 9 - 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.

Slide 10 - 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.

Slide 11 - Current inspection trends

Summary

  • More than 85% inspections are closed out on time.
  • Types of deficiencies have been provided for 2015 and 2016.
  • The new close out process will facilitate inspections are closed out in a more timely manner.

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