Saturday, May 11, 2024

Understand ICH Q7 S13

Is the lifecycle approach to process validation acceptable for APIs under ICH Q7?

Yes, ICH Q7 does not preclude the lifecycle approach [ICH Q7, 12.10, ICH Q10, ICH Q11]

Can the range of a process parameter be expanded based only on a process deviation(s)? 
No. However, information from the investigation into a process deviation(s) can be used to support expanding the range of a process parameter. Additional work and studies are normally needed to adequately demonstrate that the expanded range for the process parameter consistently produces API of the necessary quality [ICH Q7, 2.16, 12.11, 13.13]. 

Would additional process validation studies be needed to support a change in the source of an API starting material?

Any change in the API starting material should be assessed for impact on the API manufacturing process and the resulting API quality [ICH Q7, 7.14]. Additional validation studies of the API process may be warranted if the change in the API starting material is deemed significant. In most cases, validation would be expected for a different source of the starting material unless otherwise justified [ICH Q7, 12.1, 13.13]. 

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