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July 2020

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Subject:
From:
Timothy Cser <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 20 Jul 2020 20:00:12 +0000
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Hi Kristen.  What is the article failing to be neutralized and what have you tried so far?

Sincerely,

Tim Cser
MilliporeSigma

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Kristen Peters
Sent: Monday, July 20, 2020 8:26 AM
To: [log in to unmask]
Subject: [PMFLIST] Failed Neutralization in Suitability Testing

All - does anyone know what the USP recommends if the suitability test fails using neutralizing agents? What is the next step, can we proceed with the PET/AET on the product?

Kristen Peters
General Manager
Advanced Laboratories, Inc. North Carolina
919-989-7793 <(919)%20989-7793> (NC Lab, FDA Reg #10560615298)
919-989-9226 <(919)%20989-9226>(Fax)

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