Chromatography Forum

Hello! I just started a new job at a pharmaceutical company where I will be responsible for the reference standard program. I am basically self-teaching myself about all standards matters. So far, I know my responsibilities will include developing and implementing a records system, and overviewing the complete qualification and calibration plan.

What are the most common records systems used for standards management?
Are there any any official regulations or guidance documents I should follow?
Is there any other important responsibility regarding standards that I may be overlooking?
Do you have any advice or insights regarding this matter?

All your comments welcome.

Thanks in advance.

Somewhere in the first few pages of your company's QC policy it will say something about staff being appropriately qualified, experienced and trained - get your boss to send you on some courses.

Peter

Hi Peter,
You are correct. I did read that on one of my first days.
However, I am still waiting for someone to have to have the time to give me the training I need, so for the time being I am just trying to learn for myself, reading and searching. That's actually how I discovered this forum. I was hoping I could get some advice here.

As I recall there are no regulations per se for 'reference standards' except good GMP documentation requirements. Therefore, I would have an individual card for each reference standard;

1. Initiated when received stating by whom and date as well as the actual value of the molecule of interest. I would also include the initial weight and the conditions of storage.

2. Date used with analysis by whom and date as well as amount used.

3. Date decommissioned.

4. Other...

I presume this documentation will be reviewed by a regulatory inspector.

If you are starting from scratch then a good first step is to define what will be meant by "reference standard", "certified reference material", "primary standard", "working standard" etc etc when you use those terms in the documentation. If you can align all your definitions with the official guidance in whatever QC system you work in, so much the better. Mercifully I have not worked under formal QC for quite a while so I am not up to date with the latest references, but there are lots of experts in that area who will chime in.

Peter

DR wrote:

How can there be a 9 in the lower right when there are only 8 surrounding squares?

Been a while since I had time for Mine Sweeper