Regulatory Open Forum

Hello all,

I would appreciate your insights regarding the validation of filters. I have recently received feedback from two separate vendors, and I would like to kindly request your opinions and feedback on the matter.

1. 1. At what phase of development would the filter validation need to be completed:  before Phase 3 or during phase 3? 

1. 2. How many batches of material should be tested?  If only one batch is needed, is the material made in R&D lab (at a smaller scale) suitable?

1. 3. Filter validation scope:
      1. given that a filter integrity test is conducted in each GMP production, is it required  (or optional) to do this test during validation?  If required, what is done during validation that is different than during GMP production?

Thank you for your time. 

Hello all,

I would appreciate your insights regarding the validation of filters. I have recently received feedback from two separate vendors, and I would like to kindly request your opinions and feedback on the matter.

1. 1. At what phase of development would the filter validation need to be completed:  before Phase 3 or during phase 3? 

1. 2. How many batches of material should be tested?  If only one batch is needed, is the material made in R&D lab (at a smaller scale) suitable?

1. 3. Filter validation scope:
      1. given that a filter integrity test is conducted in each GMP production, is it required  (or optional) to do this test during validation?  If required, what is done during validation that is different than during GMP production?

Thank you for your time. 

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sein pyo
Edgewood WA
United States
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