All,
Here's some information that may help understand
the parameters. My firm has supplied firms in
the industry for years with products that
incorporate an expiration date. If a supplier
manufactures a product and places an expiration
date on the product and the product expires
several concerns arise in extending the
expiration date.
1. Is the product still good? Stability,
Sterility, etc.....All pertinent aspects need to
be tested. We have some products that will
remain sterile well past the expiration date,
however, stability of the solution is compromised
after that date.
2. The expiration date remains on the product
for all to see. And if expired, it is expired.
Having product in or around operations that show
an expired date on the product is not advisable.
And so, if testing to extend the date is to be
done and is proven acceptable, then re-dating of
the containers by the firm doing the testing
would be a must for future lots that are received.
3. Extending an expiration date means a firm
will test "X" product appropriately. And the
date it was tested, it hopefully passed. If it
passed, it can be used on that day. Not the next
day as one did not test the next day. In short,
you cannot test a product and then assess 30, 60
or 90 days from the date you tested it as you do
not know what happens 30, 60 or 90 days from the
date tested. You only know what occurred the day
you tested it. Not in the future.
4. To add future dating (like 30, 60 or 90 days)
you must test an expired lot for those time
periods and then apply them to a new lot coming
in. Not the same lot tested for the reasons in
#3.
Normally expired product comes to fruition from
over purchasing, temporary shutdown of
operations, short dating by the supplier and/or
poor inventory management. All of these are
business functions that need to be corrected for
future operations. Rather than extending dating,
I'd suggest correcting the problem.
Hope this helps,
Art Vellutato, Jr.
V.P. Technical Support Operations
Veltek Associates, Inc.® and Aseptic Processing, Inc.®
Artjr@sterile.com
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