Regulatory Open Forum

Hi,  

I am new to the RA field and would like to get some help in evaluating raw material change.

During manufacturing, our product is stored on the plastic side of the by-layer liner for a short period of time. We must replace this liner with another one that has the same plastic side but different paper side (does not touch the finished product). This liner is not our primary packaging, as a result it is only specified in batch records and development documents in our submission.

From going through the regulations, my initial assessment is that this change can be reported in annual report along with the updated batch records.

I would like to confirm if this in fact should be reported in annual report?

If we perform equivalence assessment would we need to place some FP lots on stability after manufacturing?

Thank you

Interesting question...I dealt with a storage change for a raw material not long ago. Just from the FDA side (not considering EU or other countries), the company assessed the storage change through 21 CFR 820.70(b), 820.75, and 820.40. These were helpful: presentation and SG3
https://www.fda.gov/media/118200/download

https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

To answer your question about the annual report, yes this company placed the finished validation in the annual report. But not until the company determined that the change did not introduce a risk to the product (like the human factor of putting it up backward, etc.) and the validation results showed equivalence. The OQ testing for that product included process control limit testing and determined the need for real-time stability lots after the validation.

I look forward to hearing from the other members and how they've dealt with this type of issue.

Hi,  

I am new to the RA field and would like to get some help in evaluating raw material change.

During manufacturing, our product is stored on the plastic side of the by-layer liner for a short period of time. We must replace this liner with another one that has the same plastic side but different paper side (does not touch the finished product). This liner is not our primary packaging, as a result it is only specified in batch records and development documents in our submission.

From going through the regulations, my initial assessment is that this change can be reported in annual report along with the updated batch records.

I would like to confirm if this in fact should be reported in annual report?

If we perform equivalence assessment would we need to place some FP lots on stability after manufacturing?

Thank you

Hello Valeria,

Could you clarify what types of materials or stage in manufacturing you are asking the question?  As an example, are you speaking about raw materials going into medical devices, sub-assembly of medical device, raw materials going into drug substance, drug substance itself, etc.?  If may be possible to handle different materials thoughout the storage and processing differently depending on the stage of manufacturing.

Interesting question...I dealt with a storage change for a raw material not long ago. Just from the FDA side (not considering EU or other countries), the company assessed the storage change through 21 CFR 820.70(b), 820.75, and 820.40. These were helpful: presentation and SG3
https://www.fda.gov/media/118200/download

https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf

To answer your question about the annual report, yes this company placed the finished validation in the annual report. But not until the company determined that the change did not introduce a risk to the product (like the human factor of putting it up backward, etc.) and the validation results showed equivalence. The OQ testing for that product included process control limit testing and determined the need for real-time stability lots after the validation.

I look forward to hearing from the other members and how they've dealt with this type of issue.

Hi,  

I am new to the RA field and would like to get some help in evaluating raw material change.

During manufacturing, our product is stored on the plastic side of the by-layer liner for a short period of time. We must replace this liner with another one that has the same plastic side but different paper side (does not touch the finished product). This liner is not our primary packaging, as a result it is only specified in batch records and development documents in our submission.

From going through the regulations, my initial assessment is that this change can be reported in annual report along with the updated batch records.

I would like to confirm if this in fact should be reported in annual report?

If we perform equivalence assessment would we need to place some FP lots on stability after manufacturing?

Thank you

Hi,  

I am new to the RA field and would like to get some help in evaluating raw material change.

During manufacturing, our product is stored on the plastic side of the by-layer liner for a short period of time. We must replace this liner with another one that has the same plastic side but different paper side (does not touch the finished product). This liner is not our primary packaging, as a result it is only specified in batch records and development documents in our submission.

From going through the regulations, my initial assessment is that this change can be reported in annual report along with the updated batch records.

I would like to confirm if this in fact should be reported in annual report?

If we perform equivalence assessment would we need to place some FP lots on stability after manufacturing?

Thank you

First, I must clarify that I have no direct experience with this type of product. That said, it all goes back to potential to impact product quality.

Given that this is not the primary or even secondary packaging and that there is no product contact of the paper side, I would say that a change in just the paper would not be reportable as there is no potential to impact product quality.

If there is a change in the product contact material (i.e., the plastic side), and you have a risk assessment showing low potential to impact product quality, then AR would be sufficient in the US. 

From your description, this doesn't seem any different than if you changed the material of contact for any other piece of equipment used in the manufacturing process. Whether that material has the potential to impact the inherent stability of the product after it's no longer in contact with it should be addressed by the risk assessment, but in general I can't imagine that would be the case. So I would not think that stability studies for this type of change would be needed, but that's really for your technical experts to decide and justify.

But, as I said, I don't have experience with this type of product. If you haven't already done so, you should check the post-approval change guidelines in the countries where your product is registered and also check if there are specific guidelines for that particular type of product.

Hi,  

I am new to the RA field and would like to get some help in evaluating raw material change.

During manufacturing, our product is stored on the plastic side of the by-layer liner for a short period of time. We must replace this liner with another one that has the same plastic side but different paper side (does not touch the finished product). This liner is not our primary packaging, as a result it is only specified in batch records and development documents in our submission.

From going through the regulations, my initial assessment is that this change can be reported in annual report along with the updated batch records.

I would like to confirm if this in fact should be reported in annual report?

If we perform equivalence assessment would we need to place some FP lots on stability after manufacturing?

Thank you