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June 2020

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Subject:
From:
Maria Eckhardt <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 26 Jun 2020 16:02:21 +0000
Content-Type:
text/plain
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text/plain (70 lines)
Hi Selena:

I have always had treated 3 consecutive alert as an action limit. Just like an action limit, three consecutive alerts will require investigation an corrective actions (i.e. repairs, cleaning, resampling, etc). The practice has been found to be acceptable thru all my regulatory and customer audits as a non-sterile CMO manuf. Hope this helps.

Maria
-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> On Behalf Of Selena Rossi
Sent: Friday, June 26, 2020 4:15 AM
To: [log in to unmask]
Subject: [PMFLIST] limit of allert and out of trend

Hi everybody,
do you investigate any single breach of alert levels or 3 consecutive breaches?
I work in a non sterile manufacturing (oral solid) and we want to review our procedure.

Could you suggest any guidance about alert leve in enviromental and how to manage OOT?
What is your experience about it?

Thanks in advance!
Have a good day,
Selena

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Microbiologics, Inc. - https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.microbiologics.com%2F&amp;data=02%7C01%7Cmeckhardt%40FORMULATEDSOLUTIONS.COM%7Ce126a220af49400d59dd08d819c5eb0d%7Cbb3a191583134114ade87268361e2953%7C1%7C0%7C637287685139229064&amp;sdata=njOT%2Bgtt%2BxJCEXtfuGflKtYd2yqTlbwRoLGN%2Bis8%2BTQ%3D&amp;reserved=0

BD Industrial Media - https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.bd.com%2Fds%2F&amp;data=02%7C01%7Cmeckhardt%40FORMULATEDSOLUTIONS.COM%7Ce126a220af49400d59dd08d819c5eb0d%7Cbb3a191583134114ade87268361e2953%7C1%7C0%7C637287685139229064&amp;sdata=WKko8e1hScGJKhGts5DfPV3MEE7XjAGfsXzIIROlWK4%3D&amp;reserved=0

Associates of Cape Cod, Inc. - https://nam04.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.acciusa.com%2F&amp;data=02%7C01%7Cmeckhardt%40FORMULATEDSOLUTIONS.COM%7Ce126a220af49400d59dd08d819c5eb0d%7Cbb3a191583134114ade87268361e2953%7C1%7C0%7C637287685139239060&amp;sdata=RQKUGt0Go5ppN036rrK6YSh0ro1zD7eJwT8qDSnzlcs%3D&amp;reserved=0


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Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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