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April 2015

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Subject:
From:
Selvam S <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 2 Apr 2015 05:41:28 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (145 lines)
Dear Forum members,
Schedule M still demand material expiry shall be more than product expiry. However, same can be managed as Venkat opinion with appropriate justification. In general, during process validation (3 batches)most of the companies using near expired materials as one of the criteria and product stability data constructed in such a way that no impact on API expiration during shelf life of product.
Trust, the information is useful.
Best Regards,
S.Selvam.



-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Venkat Dharmalingam
Sent: Tuesday, March 31, 2015 2:56 AM
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.

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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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The information contained in this communication is intended solely for the use of the individual or entity to whom it is addressed and others authorized to receive it. This communication or any attachment hereto may contain confidential or legally privileged information. If you are not the intended recipient, any disclosure, copying, distribution or action taken relying on the contents is prohibited and may be unlawful. If you have received this communication in error, please notify us immediately by responding to this email and then delete it from your system. No liability is accepted for any harm that may be caused to your systems or data by this message. Unless related to Company business, the opinions, conclusions and other information contained within this email are those of the sender alone and do not necessarily constitute those of Strides. Strides reserves the right to monitor emails sent to or from addresses under its control.
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Disclaimer:
The information contained in this communication is intended solely for the use of the individual or entity to whom it is addressed and others authorized to receive it. This communication or any attachment hereto may contain confidential or legally privileged information. If you are not the intended recipient, any disclosure, copying, distribution or action taken relying on the contents is prohibited and may be unlawful. If you have received this communication in error, please notify us immediately by responding to this email and then delete it from your system. No liability is accepted for any harm that may be caused to your systems or data by this message. Unless related to Company business, the opinions, conclusions and other information contained within this email are those of the sender alone and do not necessarily constitute those of Strides. Strides reserves the right to monitor emails sent to or from addresses under its control.

=================================
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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