Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

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

It is difficult to offer specific recommendations without additional details.

In general, your sampling plan and acceptance criteria for any validation should be driven by risk. Further, testing in routine production is not the same as validation testing. Before you go into production, you have to validate to confirm that all requirements, including those related to risk, are satisfactorily met based on your acceptance criteria. 

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Naveen Agarwal, Ph.D.
Problem Solver | Knowledge Sharer.
Let's Talk Risk!
@https://naveenagarwalphd.substack.com/
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Original Message:
Sent: 18-Jul-2023 13:46
From: Anonymous Member
Subject: Filter Validation

This message was posted by a user wishing to remain anonymous

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. 

I think every one would need to have a bit more details to be able to address this. First - what kind of filters? optical filters? electrical filters? fluid filters? Also, what is the USE of the filters - filter manufacturing materials? filter something in the device itself? etc

Finally, it would be really hard to have an opinion on "which phase" validation would need to be done without knowing your specific process. If it is used as part of the manufacturing process, that would be no later than during process validation, whatever phase that falls into. However, if it is a component of the device itself, I personally would want it done before heading into design verification. Different design control processes have different elements in different "phases" or perhaps no phases at all, so without the specific process it is impossible to answer.

G-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 18-Jul-2023 13:46
From: Anonymous Member
Subject: Filter Validation

This message was posted by a user wishing to remain anonymous

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.