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May 2013

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Subject:
From:
"Zuk, Dawn-Ann" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 15 May 2013 10:53:58 -0400
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Hello everyone, 
I am interested to know if the same kind of information is reported in
the APR for products that are imported, fully finished.  Stability
programs are maintained outside of the marketing country where a global
stability team is responsible for testing, data review etc.  

Would it be expected that the same level of detail is provided from the
global stability group for imported fully finished product?

Looking forward to hearing back, 
Dawn-Ann Zuk
QA Specialist, 
AstraZeneca Canada Inc.


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-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Silvia De Angelis
Sent: May-14-13 8:38 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Annual Product Review

Hi Philip,

I agree with you in all your responses to Helen.

I would like to know which stat program do you use and which stat tool
do
you use to perform multiple lot regression.

Thanks in advance,
Silvia De Angelis

Laboratorios Haymann 

-----Mensaje original-----
De: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] En nombre de Yates, Philip
Enviado el: viernes, 10 de mayo de 2013 05:51 p.m.
Para: [log in to unmask]
Asunto: Re: [PSDGLIST] Annual Product Review

Hi Helen,

Answers to your questions below:

*         In general, projects/lots placed on stability is listed.  -->
Yes, a list of all batches/lots on stability including those enrolled
during
the reporting period.  

*         Do you mention the status for each study (e.g., 9M, or 24M,
etc.)?
-->  Yes, typically study status (ongoing or complete) may be inclued
along
with the most recent time point tested.

*         Do you perform Trend analysis ?  (if you do, what attributes
do
you focus on? And the rationale) -->  Yes, trend analyses are included
for
most quantitative parameters (pH being the parameter that is not always
trended).  Multiple lot regression analyses with 95% confidence
intervals,
consistent with ICH stability guidelines, are included for all
batches/lots
that have enough data to trend.

o   How do you perform OOT (out of trend) analysis ?  -->  There is not
one
way we identify OOT results.  Typically running statistical analyses
with
trend lines and 95% CI help to identify OOT results.  Other methods
include
comparison with previous data (without trends), standard deviations from
mean, etc.  Both trend analyses and identification of OOT results are
evaluated throughout the reporting period on individual studies as new
results are generated.  We run single lot stats after each test point as
part of our routine data analysis; however, the multi lot stats are
conducted (minimally) as part of our Annual Product Review effort.  OOT
results are rarely identified during the APR authorship as they are
routinely identified throughout the reporting period as part of our data
review.

*         Do you highlight all confirmed stability failure in that year?
-->  Yes, for results within expiry/labeled storage condition.

*         How about any deviation which leads to FCA (field corrective
action) or BPDR (biological product deviation report)?  -->  typically
yes;
however, we have not had one of these in recent past.

*         What other issues do you include in the APR?  -->  any late
testing (beyond 30 days from sample removal from stability storage) with
reference to investigation and reason, any missed testing with reason
and
reference to investigation, all-stability related investigations, all
stability related change controls, discussion on impact to results as a
result of a change in reference standard, etc.


Hope this helps.

Philip Yates

Pfizer Biotech



-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Lee, Helen W
Sent: Wednesday, May 08, 2013 10:51 PM
To: [log in to unmask]
Subject: [PSDGLIST] Annual Product Review

Dear all
In your annual product review, STABILITY section, what content do you
include?  Please share with us.  Thanks.


*         In general, projects/lots placed on stability is listed.

*         Do you mention the status for each study (e.g., 9M, or 24M,
etc.)?

*         Do you perform Trend analysis ?  (if you do, what attributes
do
you focus on? And the rationale)

o   How do you perform OOT (out of trend) analysis ?

*         Do you highlight all confirmed stability failure in that year?

*         How about any deviation which leads to FCA (field corrective
action) or BPDR (biological product deviation report)?

*         What other issues do you include in the APR?

Regards,

Helen

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The
specific statements and endorsements of individuals participating in the
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the
PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
Microbiology Network (http://www.microbiol.org) 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
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BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms,
Freezers
and
   Ultra Low Storage Chambers with Complete Validation, Maintenance &
Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc.
-
http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in
chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology
supplies
    for the clinical, industrial, and molecular biology research
communities.

=================================
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
PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
Microbiology Network (http://www.microbiol.org) 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms,
Freezers
and
   Ultra Low Storage Chambers with Complete Validation, Maintenance &
Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc.
-
http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in
chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology
supplies
    for the clinical, industrial, and molecular biology research
communities.

=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The
Microbiology Network (http://www.microbiol.org) 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms,
Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance &
Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc.
- http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in
chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology
supplies
    for the clinical, industrial, and molecular biology research
communities.

=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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