Was told I needed a GLP program because I swab for microbes with color changing swabs

Hello again,

Same audit, same auditor as my last post. (Siliker, GMP)

I swab for listeria and salmonella with hygenia swabs and I can place them in their incubator and after 24-48 hours the liquid on the inside will change colors if there was any salmonella or listeria have been found. Sometimes there are false positives, we clean and re-swab, if there was any positives we would send to the lab and since we started this we have always been negative. 

However, because of these swabs (they look just like protein swabs) the auditor stated I should follow the Lab section of the audit, and that I should have a GLP program. I have searched this forum for anything and it is confusing and also way more than what we do. 

Can anyone guide me as to what I can look at for help? He said we needed a destruction log, a lock where the incubator is placed for testing which is in my office and that all of this info would be on the GLP program which I clearly dont have.

Yes, you definitely need it, regardless what GFSI scheme you have. That's for your own good. One of my clients has an in-house lab, and I created an SOP which includes testing instructions, GLP, etc. Please, see attached: hope it'd give you an idea.

Thank you so much!

Hi Larissa,

With all respect, if you do pathogen testing like Salmonella IMO you should have items like proper micro lab / disposal systems / isolated premises.

Sounds like you lack a professional microbiologist.

Hi Larissa,

 

With all respect, if you do pathogen testing like Salmonella IMO you should have items like proper micro lab / disposal systems / isolated premises.

 

Sounds like you lack a professional microbiologist.

I don't agree: we trained one of our operators to do testing with all precautions, not a big deal. We test for TC and E. Coli

I don't agree: we trained one of our operators to do testing with all precautions, not a big deal. We test for TC and E. Coli

 Hi Olena,

Yes, the topic has been debated here previously at some length but with no consensus.

My ex-sister Company in US refused to do any micro.testing in-house until it was "professionalized". Reason - too much to lose.

I hope none of yr E.coli is pathogenic.

 Hi Olena,

 

Yes, the topic has been debated here previously at some length but with no consensus.

My ex-sister Company in US refused to do any micro.testing in-house until it was "professionalized". Reason - too much to lose.

 

I hope none of yr E.coli is pathogenic.

So far - no pathogenic E. Coli. And yes - I see the reason for not building in-house labs if there's much to lose... Anyways, none of our customers or government inspectors/auditors had any comments regarding our lab practices or results. Just to add: in-house testing should be validated by accredited lab's testing.

Hygenia has their own swabs and incubator where you can check surfaces and incubate them in their own incubator. I was unaware that made me a lab in my office. We wont build another room just to incubate our swabs. We just got this system the end of last year, I took it as a way to save from sending 18 swabs a month to a lab, and it saves about $200 a month

So yea we lack a professional microbiologist because these swab change colors if there is any positive reactions.  

Hygenia has their own swabs and incubator where you can check surfaces and incubate them in their own incubator. I was unaware that made me a lab in my office. We wont build another room just to incubate our swabs. We just got this system the end of last year, I took it as a way to save from sending 18 swabs a month to a lab, and it saves about $200 a month

 

So yea we lack a professional microbiologist because these swab change colors if there is any positive reactions.  

^^^^(blue) Well, yes, sorry but I'm afraid that it really does. An unofficial one which is potentially handling pathogens.

^^^^(red) Validation ?? Ring testing ?

Sensitivity / Specificity characteristics ??