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March 2015

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 27 Mar 2015 18:57:46 -0400
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I won't do it. Although most manufacturers validated their API shelf life
well past expiration date and by making product with it you changing it
appearance, you might still have to show that the quality of the product
will not change during its life, unless it is only a few days or weeks. For
example I would use my media for testing today, even if it is going to
expire tomorrow (my test is only 3 days long). On the other hand if one of
the ingredients that I am planning to make is expiring tomorrow, my media
batch will expire tomorrow.

Hope that helped
Julie Barlasov,  MBA
On Mar 27, 2015 5:02 PM, "Radwan Almofti" <[log in to unmask]> wrote:

> Hi Everyone,
>
> Could you please let me know if I can use an API that will expire soon to
> manufacture a finished product with shelf life that will pass the expiry
> date of that API?
>
> For example, if I want to use Ibuprofen that will expire in June 2015 to
> make the tablets or oral liquid or any other finished dosage forms that has
> the shelf life of 3 years which means that Ibuprofen will expire in the
> tablets (or other dosage forms) while they are being consumed.
>
> Is that acceptable by GMP/CGMP, FDA and/or other regulatory bodies such as
> Health Canada or EMA?
>
> Many thanks,
>
> Radwan
>
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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 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.

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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