1

2

3

4

January 2018 5

6

Options for Risk Mitigation

Option 1: Common permitted concentration limits of elements across DP components for DP with daily intakes of NMT 10 g

7

Option 2a: Common permitted concentration limits across DP components for a DP with a specified daily intake: Option 2b: Permitted concentration limits of elements in individual components of a DP with a specified daily intake

Option 3: Finished Product Analysis

Options and Challenges

Options Challenges Option 1: Common permitted concentration limits of elements across DP components for DP with daily intakes of NMT 10 g

Not able to get the information from Vendor

Option 2a: Common permitted concentration limits across DP components for a DP with a specified daily intake: Option 2b: Permitted concentration limits of elements in individual components of a DP with a specified daily intake Option 3: Finished Product Analysis: It is within the limits of the

DP manufacturer as the testing can be done by the DP manufacturer itself.

8

Risk Assessment of Manufacturing Operation of Drug Product

9

Main Challenge: Risk Assessment of Synthetic Operation of API & Excipients

• Starting material • Reagents • Catalysts – Metal Catalyst • Solvents

10

Thanks for all the Industry Representatives!

11