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April 2015

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Subject:
From:
Radwan Almofti <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 2 Apr 2015 12:12:37 +0000
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Thanks everyone for the valuable input. 

Could those who said yes we can use APIs with retest/expiry dates shorter than the finished products and those who said no give any supporting regulations, guidance or anything written in this regard?

Much appreciated.

Radwan

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Venkat Dharmalingam
Sent: Monday, March 30, 2015 5:26 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] About expiry date of APIs and expiry date of finished product

The answer is Yes, you can use a API which is within its expiry soon and make a drug product using that API.

It is not necessary that the API expiration should be beyond the product expiry. Both are different things.

The Finished product expiry depends on many things not only the API expiration, but the excipients, manufacturing process, packaging configuration etc.

In case if you need to prove that the drug product will be stable, then place that lot of drug product (which was made with API expiring soon) in the stability study and determine whether the drug product can stay stable throughout its shelf life.

Thanks,

Venkat







On Mon, Mar 23, 2015 at 4:36 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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> 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.
>



--
-----------------------------------
Venkat Dharmalingam
Associate Director, QA
Novel Labs Inc
400 Campus drive
Somerset NJ 08873
Phone: 908-603-6064
Fax: 908-603-6006
email: [log in to unmask]
-----------------------------

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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.

------------------
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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