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TGA presentation given at Parenteral Drug Association Australia Chapter meeting, 24 November 2015
Manufacturing Quality Branch - 2015 achievements and challenges
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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
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
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
Slide 6 - GMP clearance processing times - average
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
- Predictable inspection close out times for manufacturers who comply with requirements
- 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.
- Reduced regulatory burden for manufacturers with repeat A1 rating
- 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?
- 2015: Achievements and challenges
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