Subject: GLP and GMP

From: "Pandey, Jaya" <JPandey*at*chla.usc.edu>
Date: Mon, 24 Nov 2003 09:31:47 -0800

Dear All,

Is anyone aware of some quality courses on-line or regular for GLP and GMP
standards mainly in Los Angeles area. Does one have to get a certificate for
getting entry into Industry?

Please reply,

Thanks,

Jaya

---

From: James Robinson <prsjjr.-at-.bath.ac.uk>
Date: Mon, 24 Nov 2003 20:18:16 -0000

In the UK, there is an excellent book by the MCA (medicines control agency, "the orange guide") and there is apparently a USA equivalent published by the FDA. GMP should be referred to a cGMP, or current good manufacturing practise. GLP and cGMP are careful working practises to track the status of a process and adherence should reflect in a reproducible product quality. A search should produce some good websites on the web. 

As for a certificate, ummm, if memory serves in the UK one can become a Qualified Person, but such people are concerned with following paperwork not neccessarily performing comp chem or modelling. I do hope such regulations never apply to modelling! Imagine that, given a notice by the FDA because your optimisation point only has a gradient of 0.0123 instead of 0.0099, wonder if would ever apply to operating systems too. The mind boggles! 

James

-----Original Message-----
From: Computational Chemistry List [mailto:chemistry-request.-at-.ccl.net]On
Behalf Of Pandey, Jaya
Sent: 24 November 2003 17:32
To: 'chemistry.-at-.ccl.net'
Subject: CCL:GLP and GMP

Dear All,

Please reply,

Thanks,

Jaya

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