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May 2011

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Subject:
From:
Vivek Bharambe <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 9 May 2011 17:54:35 +0530
Content-Type:
text/plain
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text/plain (105 lines)
Dear Shougata,

As you are saying In case of modification of existing water system e.g
extension of PW loop, replacing Reverse osmosis system, It is necessary to
perform validation because due to this your quantity and quality of ultimate
product will be modified i.e. improved

Regarding the time period in days we need to perform the PQ before resuming
production operation? It is recommended to go for 21 days unlike water
system validation / PQ.since WFI is prodcued from the PQ and modification is
also done in the PW generation system.

Regards,
Vivek Bharambe
CQA - Maneesh Pharmaceuticals Ltd.
Mumbai


---------- Forwarded message ----------
From: shougata bose <[log in to unmask]>
Date: Sun, May 8, 2011 at 12:22 PM
Subject: [PMFLIST] PQ of Water system
To: [log in to unmask]


Dear AllIn case of modification of existing water system e.g extension of PW
loop, replacing Reverse osmosis system, for how many days we need to perform
the PQ before resuming production operation?Do we need to perform the PQ of
WFI system also?since WFI is prodcued from the PQ and modification is also
done in the PW generation system?

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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

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

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

=================================
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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

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