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July 2010

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Subject:
From:
"Thomas, Dave P. [GPSUS]" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 12 Jul 2010 13:55:44 -0400
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Dear all,

 

These questions are in regard to practices for marketed stability
programs and sampling from various locations in a packaging run:

 

 

*         Are your stability samples for US marketed stability a
composite of samples that are pulled from Beginning, Middle and End
(B,M,E) of primary packaging run?

 

*         Do you do this for all products, or is it product/platform
specific (e.g., liquids vs solids), do you have different practices.  If
so, what are the differences with respect to B,M,E sampling for
stability

 

*         If (for example) bulk suspension is subdivided into multiple
fill orders, do you take B,M,E for a particular (single) fill run from
that bulk holding tank, or do you ensure your stability samples are
B,M,E across the entire bulk held in inventory until depleted?

 

*         Do you have any inspectional history related to BME sampling
for finished product stability (either FDA question/expectations and/or
comments)?

 

*         Are samples labeled B,M,E for stability for traceability?

 

*         How do you take retain samples?  Do you sample B,M,E and
retain samples clearly labeled as B,M,E?

 

 

Thank you,

Dave

 

 

David Thomas, Ph.D.

Sr. Manager, Small Molecule Method Development

PDMS - Analytical Development

Johnson & Johnson Pharmaceutical Research & Development

1125 Trenton-Harbourton Rd

Titusville, NJ 08560

Phone: 609-730-4393

email: [log in to unmask] <mailto:[log in to unmask]> 

 


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