Qualification Due Date for HPLC

[Terry]

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

[aceto_81]

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


Ace

[krickos]

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.

[Terry]

Dear Ace and Krickos,

Thanks for your reply.

Terry

[qfiviera]

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.

[DR]

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).