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GLP Audit checklist for approving a laboratory?


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#1 nataliemoodley

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Posted 03 May 2012 - 07:55 PM

hi

Apologies for bombarding this forum. I have been given the responsibility to outsource Microbiology labs for my company. I was wondering if anyone has an audit checklist that i can utilize to measure the standard of the lab, eg: glp etc.

any help will be greatly appreciated.



#2 Charles.C

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Posted 03 May 2012 - 09:17 PM

hi

Apologies for bombarding this forum. I have been given the responsibility to outsource Microbiology labs for my company. I was wondering if anyone has an audit checklist that i can utilize to measure the standard of the lab, eg: glp etc.

any help will be greatly appreciated.


Dear nataliemoodley,

It may depend on what type / sensitivity of analyses you intend to request, eg purely informative or otherwise. It is rather easier if you have (or had) yr own lab. to assess the relevant products typical micro.characteristics.

One (obvious) criterion is the possession of appropriate certification, eg ISO 17025. Theoretically this should minimise yr own necessary checking.
(If you hv a look at the relevant section in BRC6/Food, this has several basic expectations of a “lab”).

Second is to request the methodologies of yr intended range of requests if not included in the labs. standard analysis forms. This assumes you have someone competent to evaluate the input.

Thirdly, if possible, I send some relevant samples / requests where the respective micro. characteristics are reasonably well known. This again depends on yr future intentions / potential significance of the results, eg lot acceptance. This is a (very) limited version of the standard ring testing scheme.

IMEX, first impressions of micro.labs can be quite rewarding, for example no visible sign of any disposal mechanism for analysed materials can be a useful conversation starter. ;)

Rgds / Charles.C

Kind Regards,

 

Charles.C





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