Positive Controls testing for Hygiena Insite Listeria

The auditor for our GMP audit suggested that positive controls are performed for the Hygiena Insite Listeria testing that we're conductiing even though we don't operate a laboratory or follow Good Laboratory Practices. Please advise. What are best practices to avoid bringing in live listeria pathogens to perform positive controls? Here's the GMP audit guideline: The on site laboratoryis testing for pathogens, has a program in place for running positive controls and has procedures for controlling cross contamination riskand adequateseparation from any production and packaging areas.

 

The auditor for our GMP audit suggested that positive controls are performed for the Hygiena Insite Listeria testing that we're conductiing even though we don't operate a laboratory or follow Good Laboratory Practices. Please advise.

 

What are best practices to avoid bringing in live listeria pathogens to perform positive controls?

 

Here's the GMP audit guideline:

The on site laboratory is testing for pathogens, has a program in place for running positive controls and has procedures for controlling cross contamination riskand adequateseparation from any production and packaging areas.

 

Hi QAQC,

I guess you are not yet doing any Listeria controls ?.

I suggest you need to evaluate whether it is worth yr while to install an internal micro. lab rather than send samples externally.

There are many threads on this forum regarding setting up a detailed internal micro. lab. This particularly involves cost/time/technical"manpower"/factors such as in OP.

However, for Listeria, many facilities seem to use rapid tests which (are claimed) to not necessitate a "full-blown" internal micro. lab. (Based on my own experience with internal micro. labs I have some misgivings over latter assumption).

I would anticipate that suppliers of commercial, rapid, Listeria kits can directly address/answer yr positive control query.

Alternatively, external labs are typically obliged to occasionally run +ve/(-)ve controls/do ring tests.