Chromatography Forum

Posted: **Mon Dec 15, 2008 11:17 am**

Hi 2 all

Pls recommend m some good books on Pharmaceutical Analysis from practical point of view (GLP Laboratory) and can anyone give me the internet link to USP General Chapters Test Guidelines and what r the other guidelines which i should know if i m goin 2 work in a GLP Accredited lab as a Analyst

Thanx

Posted: **Mon Dec 15, 2008 11:55 am**

Hi

Regarding USP I doubt you will find an "open" link, either you need a subsrciption or the books to see the latest updates, so best suggestion, try finding it at a libery.

FDAs guidance page (http://www.fda.gov/cder/guidance/index. ... 20medicine) has a lot of guidelines and information unsure if it helps but are some about clinical (GLP) there.
But there are also some information in ICH guidelines, example chapter 19 of ICH Q7a regarding APIs for use in clinical trials, chapter 19.8 touches at analytical methods in clinical trials.

Hopefully someone better suited can give you a few more pointers.

Posted: **Wed Jan 21, 2009 2:05 pm**

One book that I would highly recommend that will covers the subjects you are interested in is the following:

James M. Miller & Johnathan B. Crowther (Editors) "Analytical Chemistry in a GMP Environment - A Practical Guide", John Wiley & Sons Inc. (2000) ISBN: 0-471-31431-5