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TGA presentation given at Parenteral Drug Association Australia Chapter meeting, 24 November 2015

Manufacturing Quality Branch - 2015 achievements and challenges

6 December 2015


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  • Presented by: Harry Rothenfluh, Assistant Secretary, Manufacturing Quality Branch, Therapeutic Goods Administration
  • Presented at: PDA Australia Chapter Meeting, 24 November 2015
  • Presentation summary: This presentation provided an update on the achievements and challenges for MQB in 2015


Manufacturing Quality Branch – 2015 Achievements and Challenges

Harry Rothenfluh, PhD
Assistant Secretary
Manufacturing Quality Branch

PDA Australia Chapter Meeting, 24 November 2015

Slide 1 - Overview

  • 2015: Achievements and challenges
    • GMP clearances
    • Inspections performance data
  • Looking ahead to 2016
    • Inspection close out process improvement
    • Rewarding consistent high levels of compliance

Slide 2 - GMP clearances

Slide 3 - GMP clearance applications

clearance applications table

Slide 4 - What are we doing to reduce clearance times?

Improving our ability to meet demand

  • OMQ restructure: aligning structure with function
  • Improved application triaging
  • Improved information management


  • Updates on TGA website
  • PDA presentations!
  • TGA - Industry Working Group on Manufacturing Quality

Slide 5 - GMP clearance processing times - median

table weeks to completion

Slide 6 - GMP clearance processing times - average

table clearance processing times

Slide 7 - Inspections

Slide 8 - What's in store for 2016?

Helping sponsors understand their role

  • GMP clearance application tool
  • GMP clearance guideline revision

Reducing impact of poor quality applications

  • Decisions will be made based on information provided by the sponsor in the application

Slide 9 - Inspection performance


  • 92% of domestic initial inspections conducted within target timelines (3 months)

2015-16 to end October

  • 94% of domestic reinspections (44/47) conducted within target timelines (6 months)

Slide 10 - What's in store for 2016?

Revised inspection close out process

  • Objective:
    • Predictable inspection close out times for manufacturers who comply with requirements
  • How:
    • No objective evidence required if acceptable CAPAs
    • Next inspection will include assessment of CAPAs
    • Limited rounds of additional information requests

Slide 11 - What's in store for 2016?

Rewarding consistent high levels of compliance.

  • Objective:
    • Reduced regulatory burden for manufacturers with repeat A1 rating
  • How:
    • 3 year reinspection frequency for A1 manufacturers of high risk products (currently 2 years)
    • Second and subsequent A1 ratings: reduced scope inspection

Slide 12 - Questions?

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