July 2010


Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
"Thomas, Dave P. [GPSUS]" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Mon, 12 Jul 2010 13:55:44 -0400
text/plain (92 lines)
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


*         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


*         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,




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]> 


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 ( is operated from The Microbiology Network ( 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.

Environmental Specialties -
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services

Calvex, LLC -
   Validation and Calibration Services

Veriteq Instruments -
   Environmental Monitoring, Alarming, Reporting & Validation