Chromatography Forum

hi. im a recent graduate and have been trying to break in to the pharma industry. the problem is that i have no experience in a GMP quality control environment. what are the most important aspects of GMP and what major problems does a quality control (HPLC) analyst face on a daily basis? is the job a constant challenge?

Hi

Well kinda hard to in short sum up current GMP in a QC lab, but very short it covers among many things:
*having tracebility ie documenting your work so it can be reviewed maybe years later by an auditor.
*following procedures and standard operating procedures (not doing things differently even though it might be sound, not using out dated solutions just because you do not think it will matter etc...)
*your work will always be checked by a second person

If you have a good lab and good analytical procedures is not very challeging in a normal QC release lab, some would perhaps call it even a bit boring.
What can be challinging or even frustrating can for example be that changes to analytical procedures may take time (typically require a so called change control handling), may require revalidation, documentation and worst case regulatory approval (countries where product is sold have to approve it).
More or less being forced to work with out dated (from a technical point of view) pharmacopiea monograph can also be frustrating, when you know that things could be done better and quicker.

thanks for your reply.
so documentation would obviously be the most important aspect.

one last question: in a highly regulated FDA environment how often would OOS results occur. what would be the procedure for handling them.

GMP-If you didn't document it, it didn't happen. So yes paperwork, paperwork, and more paperwork!

The FDA has an OOS guidance on investigations.

http://www.fda.gov/downloads/Drugs/Guid ... 070287.pdf

As for number of OOS occurences, people make mistakes, but if all GMP systems are working OOS results should be minimal.

QC work does get boring, however it is a good start for GMP and analytical training.

thanks for the link. very helpful.

GMP is 50% regulations and 50% figuring out how they apply to you, or how to apply them, or how to comply without working yourself to death. You (should) end up with a very structured approach, so when you come in at the bottom as a newbie, you'll find you have a lot of stuff laid out in procedures etc. already that you follow. The FDA is the toughest, so once you get a foothold in that kind of GMP you're set up for other things.