Dear Ms/Mr Boomish,
as I was not sure what answer to give you I've forwarded your question to
D,Begg Associates in the UK, a GMP-Consulting Company with best reputation
(adress see below) and they had the kindness to try to find an answer (see
word dokument below)
D.BEGG ASSOCIATES
10 HIGH MARKET PLACE
KIRKBYMOORSIDE
YORK, UK
YO62 6AX
Please see attached letter from Peter Smith
"G.Boomish" <boomish@hotmail.com>@www2.pharmweb.net> on 24.01.2000 18:59:22
Please respond to "RegAffairs" <RegAffairs@www2.pharmweb.net>
Sent by: <RegAffairs@www2.pharmweb.net>
To: "RegAffairs" <RegAffairs@www2.pharmweb.net>
cc:
Subject: Expiration dating
The manufacturing process of an API was changed. Earlier the API was
labeled for a five year shelf life. Three commercial size batches
were taken and the product subjected to accelerated stability studies
for six months.
Can any one clarify whether the expiry date needs to be changed to 2
years and further subjected to real time studies ?
G.Boomish
--------------------------------------------
G.Boomish
boomish@hotmail.com
Pharma Consulting
--------------------------------------------
10 High Market Place, Kirkbymoorside, York, YO62 6AX, UK.
Tel: +44 (0)1751 432999 Telefax: +44 (0)1751 432450
e-mail: mail@david-begg-associates.com
PS/LLJ
28 January 2000
Dear Theo
Re: Expiration dating enquiry
It was good to hear from you and I hope that all is well with you.
In reply to your enquiry/Mr Boomish's enquiry, the answer is
difficult to give on the basis of the information supplied. My
questions would be:-
a) What was the change and what was the process? The response would
depend on the risks associated, the amount of process knowledge and
existing stability data.
b) Which regulatory authority is involved? Some authorities have
different labelling requirements to others for expiration dating/data
requirements.
c) Is it possible commercially and legally to adopt a retest date
rather than giving an expiry date? If the supplier is unsure of the
old expiry date period and/or the change is relatively major, then it
would be prudent to move to a retest date say of 2 years and to do
further stability. As indicated in 1 and 2 above it will depend upon
these factors.
My apologies that I cannot help very much on the basis of the
information supplied. BACPAC gives advice if the market is in the
USA (available via the FDA Website http://www.fda.gov)
With kind regards once again from us all.
Yours sincerely
Peter Smith
Peter Smith
Partner
David Begg Associates
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