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October 2019

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Subject:
From:
Selena Rossi <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 29 Oct 2019 05:12:08 -0400
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Hi everyone,
how do you perform the investigation for an microbiological OOS?

I'm working in non sterile product company and we are revisioning our SOP in according MHRA guidance.
After retest on initial samples (if available) our doubts are on number of resamples. 3,6? Statistical decision?
And when the initial samples are not available (exmple enviromental samples) do you perform a new analysis with new sample?

Any suggestion will be appreciated!
Thanks in advance and have a great day everyone,
Selena

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