Manufacturing Quality Branch – 2015 Achievements and Challenges
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2015 - Achievements and challenges Harry Rothenfluh, PhD Assistant Secretary Manufacturing Quality Branch
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Transcript of Manufacturing Quality Branch – 2015 Achievements and Challenges
2015 - Achievements and challengesHarry Rothenfluh, PhDAssistant SecretaryManufacturing Quality Branch
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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
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GMP clearances
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GMP clearance applications
To 23 October
11/12 12/13 13/14 14/15 15/160
1000
2000
3000
4000
5000
6000
7000
3900 39414222
5873
1929
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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
Communication• Updates on TGA website
• PDA presentations!
• TGA - Industry Working Group on Manufacturing Quality
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GMP clearance processing times - median
0.002.004.006.008.00
10.0012.0014.0016.0018.0020.00
0
50
100
150
200
250
300
(weeks)
Med
ian
wee
ks to
com
plet
ion
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GMP clearance processing times - average
0.002.004.006.008.00
10.0012.0014.0016.0018.0020.00
0
50
100
150
200
250
300
Aver
age
Wee
ks T
o Co
mpl
e-
tion
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Inspections
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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
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Inspection performance 2014 - 15• 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)
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What’s in store for 2016? Revised inspection close out process• Objective:
o Predictable inspection close out times for manufacturers who comply with
requirements
• How:
o No objective evidence required if acceptable CAPAs
o Next inspection will include assessment of CAPAs
o Limited rounds of additional information requests
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What’s in store for 2016? Rewarding consistent high levels of compliance. • Objective:
o Reduced regulatory burden for manufacturers with repeat A1 rating
• How:
o 3 year reinspection frequency for A1 manufacturers of high risk products
(currently 2 years)
o Second and subsequent A1 ratings: reduced scope inspection
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Questions?
