Chromatography Forum

Dear all,

I got a question about how to define the qualification due date for HPLC. Let me say that the qualification tests, including signal-noise, linerity, wavelength accuracy etc, were performed from Mar 9 through Mar 15, 2012. And the qualificaition report is approved on Mar 18.

If the qualification interval is 1 year, how would you define the qualificaiton due date? Mar 8, 2013 or Mar 17, 2013? My analytical instrument qualification is silent on this, and I am trying to revise it.

Regards,

Terry

Our rule (internally):
in case of doubt: use worst case.
So I would go for 8 march


Ace

or lets say that the due date would be the 20th but your done the 18th, then I would go for the 18th. Why give away 10 days? I would assume most try to start qualification before due date in order to keep down time to minimum.

Dear Ace and Krickos,

Thanks for your reply.

Terry

In our lab the date would be the 15th, but I think if your lab complains with cGMP, and you keep your mantenance and verification anual plan on day, to set the 8th or the 17th doesn´t change much. The important thing is that you are checking your instruments according to a plan, and you are doing it when you say you have to. I wouldn´t worry about 9 days of difference. But this is my opinion, and let me tell you that I am a young chemist (29), I have long way to travel in quality and HPLC, but happy to learn.

I suspect that your HPLC is not the only piece of equipment subject to periodic requalification.
As a result, this issue is probably addressed by a more general lab procedure about routine requalification of instruments and is best not addressed in your revision to the HPLC specific procedure.

Our SOPs effectively provide for a 13 month year (example - qualified 1/2011, due 2/2012 - can't use in 2/2012 unless it has been qualified and we don't wait for report approvals unless it is an employee's 1st time qualifying).