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