[RASMB] on GMP compliance

[Zou, Qin]

Natalia,
All the techniques you mentioned in your e-mail are currently considered as not QC-friendly. As far as I know, the majority of the industry has not used these technologies for GMP activities but only for development work.

Qin (Chin)  ZOU,   Ph. D.
Pfizer Inc.

邹秦


 

-----Original Message-----
From: rasmb-bounces at rasmb.bbri.org [mailto:rasmb-bounces at rasmb.bbri.org] On Behalf Of Natalia.Markova at inovacia.se
Sent: Thursday, May 14, 2009 1:37 PM
To: rasmb at rasmb.bbri.org
Subject: [RASMB] on GMP compliance

Hello,

I would very much like to hear your opinions on how useful and 
meaningful is to have AUC under GMP compliance. I have never worked in 
a GMP compliant lab but I suspect that it could be a bit of an 
overkill in the case of AUC. We mainly use the instrument as a tool to 
validate SEC assays of our customers or to study the oligomerization 
of the target proteins in diverse drug discovery projects.
A consultant (a former boss in a QC lab of a big pharma) is persuading 
our management to have the whole set of biophysical instruments (ITC, 
DSC, AUC, DLS) GMP compliant. According to him it will make us more 
attractive to the customers such as CMO. It does not make much sense 
to me, I am not even sure if this is feasible.  But may be I am not 
updated on the matter. Your comments are very welcome.

Regards.
Natalia
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