Chromatography Forum

Hello all

I need your help again.

This time, it concerns 21 CFR, part 11. I'm looking for an article, or discussion blog, any link, or anything, that discusses the implications and applications of 21CFR part 11, specifically with respect to HPLC and/or GC.

I've checked out the USFDA website, searched the archives of chromforum, wikipedia and lcgcmag. But I haven't been able to find what I'm looking for - a perspective on how 21CFR compliance affects chromatographic practice.

Can anyone help please? If you've come across an article or paper on this subject, please let me know.

I need it for a talk on regulatory issues in chromatography. Due acknowledgement of the source will be given.

Thanks in advance!

I am by no means an expert in this so I may be wrong here, but I believe you are making a very common and fundamental error. These regulations deal with electronic records. The source of these records is immaterial. 21CFR11 is only applicable if you choose to submit electronic records to the FDA. There was a period when manufacturers stated that their software was 21CFR11 compliant. This was wrong and I'm not aware of anyone still doing this. The software cannot be compliant it can only aid you in becoming compliant. So to be compliant you must show audit trails as with any type of GxP. In the case of 21CFR11 these trails are electronically controlled. If I'm not mistaken 21CFR11 is a set of "guidelines" and as such I believe the FDA have stated that they will not issue warning letters for not following them to the letter.

Hi Ary

Thanks for your response. I do know that 21CFR-11 is only a set of generic guidelines. I'm also aware that software by itself cannot be "compliant'. You're right, many vendors have stopped making these claims.

What I am looking for is an article or a viewpoint on how 21CFR affects the practice of chromatography. I've visited the FDA website and downloaded the guidelines, but I was hoping that someone would offer an opinion on what these guidelines would mean to a chromatographer in the lab.

For example, what would the term "audit trail" mean to a chemist developing HPLC methods?

How would I explain what "xml" means to a chemist?

I know I sound a bit vague on this, but I hope someone would be able to take this discussion forward.

Thanks for taking the time to respond.

SKS

Sorry if I'm repeating myself, but I thought I'd clarify this a bit more. I'm giving a talk entitled " 21CFR and you", to a group of chemists with a good working knowledge of HPLC, but little or no understanding of software validation issues.

I'm more or less in the same boat as they are! Good working knowledge of HPLC, but I go "Eh what?", when it comes to software validation and computer jargon.

So how do I explain 21CFR to them? That's my problem!

Help!

SKS

Hi SKS

I guess the very simple answer is, if these guys understand GLP then its really an electronic version of record keeping on those lines. Not a very satisfactory answer but hopefully one they will understand and you can build upon. I've done a quick search and ACDLABS, Galaxie and NuGenesis all have material you may be able to use for your presentation. I would expect Waters and Agilent to have something on their web sites too. The ACD web site showed an example of an audit trail for an HPLC method development for the identification of an impurity or a metabolite (was only skimming the article). You may even be able to get the info you require directly from one of these companies. Good luck I know that whenever GLP or 21CFR-11 gets mentioned there's usually a big groan goes up.

Steve

Just found this when I was searching for something completely different
http://www.lcgceurope.com/lcgceurope/da ... rticle.pdf

HI Steve:

THANK YOU. The LCGC article is useful. I visited ACD website too and got some good pointers.

At least, I now have a starting point for my lecture. I'm expected to speak on CFR for half an hour, so I think I can manage!

A few years ago we upgraded computers and firmware and had Agilent Chemstor installed; this automatically archives all your keystrokes and makes an audit trail. I don't claim to be able to withdraw all that information, but an auditor theoretically could; if I learned how I'd absolutely forget it within a month anyway. So for us, we have to sign on as ourselves, so such data is "assigned" to an individual, and files cannot be deleted or altered except by the administrator. And every few months we have to "create" a new database as ours fill up to about 650 MB. So, other than administering the computer rights of others, signing on all the $%&#$%@%^&$ time, and creating additional databases, the ChemStation works absolutely the same.