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March 2012


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ADRIAN AMODIA ALMEIDA <[log in to unmask]>
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Mon, 5 Mar 2012 18:10:23 -0800
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Hi Deepica
My understanding is that eventhough your method has been validated by an outside lab you need to prove that it works under your conditions, so yes u need to validate.  
Now specifically methods described under <61> <62> don't need full validation, just suitability will suffice. There is a little explanation under each chapter on how to perform it.
In order to validate the temperatures, once you perform at least tree replicates of the test under the specified temperatures and u prove good recovery, you are good to go.
I hope this help

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