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February 2016

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From:
Agenildo Bastos T&B Pharma Consulting <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 29 Feb 2016 07:16:42 -0300
Content-Type:
text/plain
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text/plain (171 lines)
Hi, All,
Please see 02 very nice guidelines related to this topic.

MHRA - Data Integrity
https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/4
12735/Data_integrity_definitions_and_guidance_v2.pdf
http://www.ispe.org/uk/23-apr-2015/mhra-data-integrity-guidance-expections.
pdf


WHO - Data Management
http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidanc
e-on-good-data-management-practices_QAS15-624_16092015.pdf





Best Regards,
Agenildo
Bastos
Consultant
GMP   
Phone: +55
11 97336-7788, 11 98228-5883







On 2/27/16, 14:41, "The Pharmaceutical Microbiology Forum Email List on
behalf of Tony Cundell" <[log in to unmask] on behalf
of [log in to unmask]> wrote:

>Like many lab managers I have encountered data integrity issues during my
>career.
>
>The primary causes are management requesting failing batches be released
>and ordering test data be changed, lab workers changing failing to passing
>data as a result of managerial pressure without direct orders, lab worker
>overwhelmed due to the work load creating lab results without running the
>tests, and  lazy lab workers who do not want the effort to run the tests.
>
>How do you detect data integrity issues. Look for surges in tests
>completed
>and approved in an unrealistic amount of time, reconstruction of paper or
>electronic records, too perfect data sets, test results generated out
>chronological sequence, lab workers very uncomfortable in responding to
>questions, an overall pattern of poor GMP compliance, etc.
>
>
>On Sat, Feb 27, 2016 at 12:02 AM, Bittu Dave <[log in to unmask]> wrote:
>
>>  sDear all: Given the increased scrutiny for data integrity, what arethe
>> steps pharmaceutical manufacture should take to ensure that there is no
>> breaches of  data integrity.  What inspectors are looking for? Thanks in
>> advance.Best RegardsBittu y for data integrity
>>
>> ------------------
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>>
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>>
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>>
>> BD Diagnostic Systems - http://www.bd.com/ds/
>>
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>>
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>>
>> Charles River-Endosafe and Accugenix - http://www.criver.com/emd
>>
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>>
>> Steris - http://www.sterislifesciences.com/
>>
>> 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.,
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>>
>
>
>
>-- 
>Tony Cundell, Ph. D.
>Consulting Microbiologist
>Email: [log in to unmask]
>Phone: 914 725-3947
>Cell: 914 841-0074
>
>------------------
>The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
>The Microbiology Network (http://microbiologynetwork.com) and supported by
>our sponsors 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.
>
>Accuratus Lab Services http://www.accuratuslabs.com/
>
>Associates of Cape Cod, Inc. - http://www.acciusa.com/
>
>Nelson Labs - http://www.nelsonlabs.com
>
>BD Diagnostic Systems - http://www.bd.com/ds/
>
>Biolog - http://www.biolog.com
>
>Analytical Research Labs - http://arlok.com/
>
>Charles River-Endosafe and Accugenix - http://www.criver.com/emd
>
>Microbiologics, Inc. - http://www.microbiologics.com
>
>Steris - http://www.sterislifesciences.com/
>
>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.

------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors 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.

Accuratus Lab Services http://www.accuratuslabs.com/

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

Nelson Labs - http://www.nelsonlabs.com

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

Biolog - http://www.biolog.com

Analytical Research Labs - http://arlok.com/

Charles River-Endosafe and Accugenix - http://www.criver.com/emd

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

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

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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