Dear Jessica,
If both the configurations are in use in regular production, annual stability has to be carried out without fail.
If earlier PM is not in use,then there is no need for stability of that configuration.
Regards,
Sanjay Dwivedi
Panacea Biotec Ltd
________________________________
From: Afsar <[log in to unmask]>
To: [log in to unmask]
Sent: Monday, 17 September 2012 9:15 PM
Subject: Re: [PSDGLIST] Annual commitment for new primary package
Hi Jessica,
There is no direct guidance in this regards whereas you will find
bracketing/matrix approach in ICH. It depends upon the internal SOP
and approach for the annual stability program on sound scientific
rational. As both packing configurations are equivalent and I suppose
one time accelerated and long term data already generated. In this
case What I suggest you to generate data on both configuration A & B
annually and based on sufficient data which further strengthen the
equivalence of both configuration i.e 3-4 multiple batches and
subsequently reduce one packing configuration.
Best Regards
Afsar
Wockhardt Ltd
On 9/7/12, Jessica Wong <[log in to unmask]> wrote:
> Dear Stabilitarians,
>
> Is there a requirement to place annual representative lot for each primary
> packaging configuration? If not, what is your company's practice? I cannot
> find any answer under SUPAC nor ICH.
>
> For example:
>
> Primary package A was approved and used for many years.
>
> Primary package B was just approved but already proven to be equivalent to
> Primary Package A.
>
> Both are approved for packaging at the same packaging site.
>
> (1) If we continue to use both configurations (A & B), is there a
> requirement to place both on stability as the annual representative lots?
> (2) If there is no requirement, do you alternate each configuration?
> i.e. Annual lot on Packaging A in 2012 and annual lot on Packaging B in
> 2013.
> (3) Or do you matrix the time points for both configs and place both on
> annual stability?
>
> Please advice.
>
> Thank you,
>
> Jessica
> Gilead Sciences
>
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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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
=================================
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.
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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.
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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
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