3 replies to this topic

[Lelouch_rayne]

Hi guys,

 

Anyone familiar with LACF filling in USFDA? 

 

I recently submitted Electronic Process Filing Form FDA 2541g through USFDA portal with following details.

 

Product Name - Coconut Cream

Comments section of the form - The aseptic packaging system is applicable to all containers sizes available on-site packed on the same filler equipment: 1000L, 200L, 20L, 5L, 3L and 1L. Both product and packaging sterilization process are based on coconut cream 24% fat content product formulation (no binders/starch added).

 

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Based on the above information, do we need to file for a separate USFDA form if:

 

1)  We increase the fat content of coconut cream to >30%? 

The process information I provided in previous process filling was actually applicable also for >30% fat content. 

 

2) We develop new product variation with added binders?

Even though only slight changes in product viscosity will happen if we add this to formulation (maximum % of binder to be added - 0.20%).

 

3) We run coconut skim milk on the same line? Using the same process schedule for both product and packaging sterilization process schedule as stated on previous process filling. Skim Milk is actually a by-product of coconut cream if you separate the fat content through centrifuge. So, basically it's a cream with reduced fat content (maximum 2.5%) and viscosity.

 

 

Hoping for guidance and clarifications regarding this matter.

 

 

Thanks,

Lelou

[Fishlady]

Hi, Lelou

 

If your change is significant enough to result in a change to your scheduled process, then you need to file a new SID with FDA.

[Fishlady]

And in any case, I would suggest re-filing or updating your filing to reflect any additional products that would be covered by the same scheduled process.

[Lelouch_rayne]

Hi, Lelou

 

If your change is significant enough to result in a change to your scheduled process, then you need to file a new SID with FDA.

 

Hi Fishlady,

 

Actually, we used the same scheduled process for all products. During validation process (sterility test), >30% fat content was used to test the line which basically the maximum fat content of our product. 

 

However, the certification we got from the line equipment manufacturer only indicated that "the line is suitable for 24% fat content". We tried to persuade them to change the document but they did not want to. So, to make sure that the process filling will not be complicated and not to confuse the USFDA, I followed the certification and indicated 24% instead of >30% fat content.

 

Honestly, the whole scenario is messed up just because the line manufacturer is hard-headed. They are actually the one who recommended to run >30% fat content during validation study and now they won't admit that the line can be used for >30% fat content.