In 2015, the Manufacturing Quality Branch achieved improvements in GMP clearance times and inspection performance while also facing ongoing challenges. Key accomplishments included: - Reducing median GMP clearance processing times from 18.8 weeks to 4.1 weeks through process improvements and increased communication. - Completing 92% of domestic initial inspections and 94% of domestic reinspections within target timelines. Looking ahead to 2016, plans include further streamlining the GMP clearance and inspection processes through application improvements, clearer sponsor expectations, and rewarding consistent compliance through less frequent inspections for high-performing facilities. The goal is more predictable timelines and reduced regulatory burden.

1. 2015 - Achievements and challenges
Harry Rothenfluh, PhD
Assistant Secretary
Manufacturing Quality Branch

2. 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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3. GMP clearances
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4. GMP clearance applications
To 23 October
3900 3941
4222
5873
1929
0
1000
2000
3000
4000
5000
6000
7000
11/12 12/13 13/14 14/15 15/16
4

5. 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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6. GMP clearance processing times - median
08-19
June
22-03
June-July
06-17 July 20-31 July
03-14
August
17-28
August
31-11
August-
September
14-25
September
28-09
September
-October
12-23
October
Median 18.80 14.14 9.86 9.43 7.00 5.43 8.07 3.86 4.14 4.86
Number of Applications 153 257 161 182 183 170 106 111 94 101
0
50
100
150
200
250
300
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
18.00
20.00
(weeks)
Medianweekstocompletion
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7. GMP clearance processing times - average
08-19
June
22-03
June-July
06-17 July 20-31 July
03-14
August
17-28
August
31-11
August-
September
14-25
September
28-09
September
-October
12-23
October
Average 17.71 14.92 11.93 12.25 9.99 8.81 11.32 6.16 5.42 10.55
Number of Applications 153 257 161 182 183 170 106 111 94 101
0
50
100
150
200
250
300
0.00
2.00
4.00
6.00
8.00
10.00
12.00
14.00
16.00
18.00
20.00
AverageWeeksTo
Completion
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8. Inspections
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9. 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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10. 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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11. 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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12. 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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13. Questions?
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