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Does an IND application necessitate reanalysis of a Food Safety Plan?

Food Safety Plan 21 CFR Part 117 FSMA hazard analysis risk-based preventive controls IND application

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#1 matthewcc

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Posted 11 June 2018 - 10:08 PM

Hi everyone, does an 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



#2 Charles.C

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Posted 12 June 2018 - 12:33 AM

Apologies for ignorance but what is "IND" ?


Kind Regards,

 

Charles.C


#3 matthewcc

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Posted 12 June 2018 - 02:30 PM

@Charles.C Sorry - it's an investigational new drug.







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