Microbiology Testing Outsourcing - Transport Qualification and Risk Assesssment

raghu_1968

Involved In Discussions
#1
We already have the microbiology lab and due to some unavoidable reasons, planning to outsource the microbiology analysis (product and water).

As part of risk assessment we are planning for the following.

1. Gap analysis of microbiology procedures between the outsourced lab and ours.
2. Transport qualification. (As the lab is some 25-30 kilometers distance, we are planning for this)

The query is,

a. Apart from the above did anything needs to be covered under risk analysis? And
b. What are all the things to be covered under transport qualification? (Planning to carry the samples in the freezer box) and how to fix the acceptance criteria?
 
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Ajit Basrur

Staff member
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#2
We already have the microbiology lab and due to some unavoidable reasons, planning to outsource the microbiology analysis (product and water).

As part of risk assessment we are planning for the following.

1. Gap analysis of microbiology procedures between the outsourced lab and ours.
2. Transport qualification. (As the lab is some 25-30 kilometers distance, we are planning for this)

The query is,

a. Apart from the above did anything needs to be covered under risk analysis? And
b. What are all the things to be covered under transport qualification? (Planning to carry the samples in the freezer box) and how to fix the acceptance criteria?
Question a -

I would have an Agreement in place that defines

1. roles and responsibilities
2. additional info on testing the samples within 24 hours of receipt (it is ideal that the samples are tested within 48 hours and thus your lab has to send the samples on the same day).
3. Data and results reporting incl. how to handle OOS with clear escalation path
4. the lab should follow GMP, GLP and your lab requirements.

Question b.

1. Probably you would already have addition of Sodium thiosulphate solution. Sodium thiosulphate neutralizes any residual chlorine in samples at the time of collection and prevents it from acting on any microorganisms present in water samples.
2. You may perform Validation of Microbial Recovery per USP <1227>.
 
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