5 replies to this topic

[matthewcc]

Hi everyone, does an investigational new drug (IND) application always necessitate reanalysis of a Food Safety Plan under FSMA?

 

'§117.170 Reanalysis' states that one reason that reanalysis would be required is "Whenever a significant change in the activities conducted at your facility creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard..."  However, by its very nature an IND is novel and therefore a potential new hazard could be involved.

 

We are regulated under 21 CFR Part 117 and 21 CFR Part 111 in the United States.

 

Thank you,

 

Matthew

[Scampi]

I am not familiar to your process, HOWEVER re evaluation is a HACCP requirement

 

So you should run a H.A. on the new product and it's ingredients to ensure it doesn't negatively impacting existing product flows

 

I would think (and i'm not an expert in drug manufacturing at all) that if you're just running a small trial, you can manage that via controls (segregation of raw materials, HOLD tags etc.) until you're sure the final product is going to fly, then reevaluate your HACCP plan

 

You won't know if you have a "significant" change until your hazard analysis is complete (for example, you could have new lines over exposed product, new allergens, new machine with a potential to introduce foreign material etc)

[Charles.C]

Food Safety/FSMA relates to drugs ? Really ? Manufactured in same Environment ?

[Scampi]

FDA= Food AND DRUG administration!

[Charles.C]

FDA= Food AND DRUG administration!

 

So FSMA should be FDSMA.

[Scampi]

Yep, when it comes to things like this---salmonella in a supplement

 

https://www.fda.gov/...s/ucm597265.htm