Implementing micro testing of dietary supplements finished product

Hi every one.........

we recently certified GMP (dietary supplements company) from NSF. But auditor report is saying it is necessary to start micro testing for finished product.
we are planing to start testing for total plate count, yest & mold and ecoli.
I came to know that we are not allowed to do e.coli testing within the company even in separate laboratory, is it correct?
We just want to look for E.Coli positive/negative using 3M petrifilm at least for internal verification, not to report on COA as our result does it works?
please suggest me.......??

I think you could look further into it. I am not familiar with the method you mention but the logic is that culturing of potential pathogens is a risk with the facility.

George

Hi every one.........

we recently certified GMP (dietary supplements company) from NSF. But auditor report is saying it is necessary to start micro testing for finished product.
we are planing to start testing for total plate count, yest & mold and ecoli.
I came to know that we are not allowed to do e.coli testing within the company even in separate laboratory, is it correct?
We just want to look for E.Coli positive/negative using 3M petrifilm at least for internal verification, not to report on COA as our result does it works?
please suggest me.......??

Dear santhu,

Not quite clear to me as to "Who" is not allowing the analysis ? Company regs or Federal / Local regs ?
I presume you mean generic E.coli rather than E.coli O157 ? (don't remember if in theory both can be cultivated from the same starting procedure, if so then the risk is more obvious).

If company regs, then I guess it's final. If otherwise i presume it's written down somewhere ?

Rgds / Charles.C

Thanks Charles,
It is not company reg.... I guess it is a federal reg.
Yes, it is generic E.coli.

Dear santhu,

Not quite clear to me as to "Who" is not allowing the analysis ? Company regs or Federal / Local regs ?
I presume you mean generic E.coli rather than E.coli O157 ? (don't remember if in theory both can be cultivated from the same starting procedure, if so then the risk is more obvious).

If company regs, then I guess it's final. If otherwise i presume it's written down somewhere ?

Rgds / Charles.C

Hi George,


we are trying to establish it out side of company.

Thank you very much,

I think you could look further into it. I am not familiar with the method you mention but the logic is that culturing of potential pathogens is a risk with the facility.

George