IUBio

Bioburden Testing

Jorge1907 jorge1907 at aol.comcom
Thu Mar 16 05:42:23 EST 2000


Hillary:

This is not an easy analysis but a necessary comparison better down now rather
than after you've got in-house folks doing the job.
In setting it up in house, you also need to consider the costs of (new)
employees themselves (management of their careers, retirement, space, ongoing
training, etc) as well as of their efforts peripheral to the obective (gen co.,
validation, GMP's, safety etc.).

For the outside lab, don't presume it's just submitting samples and waiting fo
results.  Consider your costs of management- however well qualified they may
be, you'll still need to troubleshoot ongoing and untoward results to ensure
accuracy and make sure they keep up on all appropriate programs.  In selecting
one, also consider how samples will be delivered, how their folks are qualified
and trained, validation of their methods, any exp. they've had with FDA, etc.
both generally and with your kinds of tests and products.
There are more things in heaven and earth, Horatio,
Than are dreamt of in your philosophy




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