Chromatography Forum

Hello Everyone, After a little time off I'm finally back in the lab!

I'm working as a contractor over at Boston Scientific (Still in the Twin Cities). My main project is Elution Assays for drug collars on medical devices. I'm very excited to be working in the Pharm area! My previous position was a lab that supports the Fuel Ethanol industry, (looking for acids as an indication of bacterial contamination) in the field samples. So I'm looking for advice to help me "hit the ground running again"

Does anyone have any advice for: background reading, hints, tricks, or pitfalls that I should be aware of? I'm open to all comments, don't hold back! Thanks everyone!

Assuming you're in a GMP environment, Know your SOPs.

When in doubt, consult your SOPs - they're much more reliable than an alarming percentage of your coworkers are.

I agree with DR. The major issue with pharmaceutical analysis is that quality systems rule, OK!.

I recommend reading the ICH quality series guidelines, especially Q7, which defines cGMP for active pharmaceutical ingredients.

Although APIs are not directly related to medical devices, once you've finished that, you will have an excellent overview of the whole pharma quality process for active ingredients, and you can then look at some of the earlier Q series documents that cover specific aspects, and also those covering medical devices.
http://www.ich.org/cache/compo/363-272-1.html

The other tome to investigate is the the current USP/NF ( which is expensive, but your workplace should have a copy somewhere ), especially the first section ( General Notices and Requirements ) and also the relevant sections of the General Chapters of the USP, denoted as <621> etc., near the back of the USP, but in front of the NF section.
The section titles are fairly self-evident but arranged according to test type, however the turgid text of some chapters is worth a cursory investigation, at least.

Congratulations, and good luck.

Please keep having fun,

Bruce Hamilton

the one vital thing I would say is that in a regulated (GxP) environment is to get accustomed to interacting comfortably with the QA Groups.

Remember also, that they may know less about the "science" than you do and if you can justify your reasoning then don't be afraid to. Doing something "just because QA told you to" is not a valid argument if it's wrong.

Also In a regulated environment even the simplest tasks often take much longer than in non regulated facilities (normally due to the increased documentation)

A book you might find highly useful in this arena is:

"Analytical chemistry in a GMP Environment - A Practical Guide" Edited by James M. Miller & Jonathan B. Crowther, John Wiley & Sons, (2000) ISBN 0-471-31431-5