PharmPK Discussion - USP Dissolution apparatus qualification

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On 13 Feb 2004 at 15:48:55, eric.magnan.-at-.ipsen.com sent the message


       Dear forum members,
Here is my question :
We use for a routine analysis an USP dissolution apparatus type 1
(basket)
and the instrument is qualified according to USP method(Desintegration
and
non-desintegration test).
But for a new analysis we are going to need mini paddles and small
vessel
(100ml).
Does the fact that we are going to use paddle means that we need to
qualify
the apparatus also with paddle too?, or  the qualification already done
with
basket is it sufficient for both methods??
Thanking you in advance for your comment on this topic
Eric MAGNAN
IPSEN PHARMA BIOTECH
Dpt Contr\0xD9le Qualit\0xC8/Quality control Dept
Service Pharmacologie/Pharmacology Unit
Tel : 33 (0)4 94 10 76 74  Fax: 33 (0)4 94 10 76 92
eric.magnan.at.ipsen.com

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On 13 Feb 2004 at 22:38:12, =?ISO-8859-1?Q?Fr=E9d=E9ric_DOC?= (fredericdoc.at.netcourrier.com) sent the message


Hi Eric,
you have to qualify your apparatus as it can be considered as a new
apparatus due to the replacement of the basket system by the paddle.
Regards,
Frederic Doc (ex PFIZER)
CEO, ADFINIS Consulting

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