HPLC machine certification

[tarzan11_11]

Dear All,
Does a HPLC machine require a periodic certification by an independent authority ..?

with best wishes

[dblux_]

Dear All,
Does a HPLC machine require a periodic certification by an independent authority ..?

with best wishes

Not mine
LOL

[DR]

If you work in a regulated lab and are encumbered with SOPs that say it is required, then it is required.


Consult your SOPs.

[tkubowicz]

Hello

I've never heard of "periodic certification".
HPLC definitely needs:
1.Periodic Preventive Maintenance (no matter if it is GxP or non-regulated lab)
2.Performance Verification/Operational Qualification (depends on regulations - GxP etc.)

Time interval depends on specified procedures. I'd say normal frequency is 1 year, however it can be different for HPLC usage/throughput etc.

It is good practice to monitor and notice any instrument activity - PM, diagnostic tests, calibration etc.

Regards

Tomasz Kubowicz

[tarzan11_11]

Thank you all

"2.Performance Verification/Operational Qualification (depends on regulations - GxP etc.)"


what exactly does this involve ..?

[tom jupille]

what exactly does this involve ..?

That depends!

First of all, are you working in a highly regulated area (e.g., pharmaceutical, clinical, environmental, etc)? if you are not, then any requirement for "certification" would be defined by government regulations (Canada is different from the US and Quebec is different from Ontario).

If you are working in a regulated area, then are you subject to GLP (Good Laboratory Practice) or GMP (Good Manufacturing Practice) regulations? If you don't know, find someone in your company who works in "regulatory affairs" whether your lab is subject to those regulations (things like QC will certainly be subject to GMP; development labs, formulations, pharmacokinetics probably GLP; early-stage discovery may not be covered by either).

If you fall under the "GxP" umbrella, then you should have SOPs (Standard Operating Procedures) in place that define how and how frequently you do instrument Qualification. Your instrument manufacturer should be able to provide you with draft procedures for PQ (Performance Qualification) of your systems, but you will probably have to adapt them to fit the specifics of the kinds of things you are doing. Commonly, SOPs will require that PQ be carried out any time an instrument is returned to use after service in order to verify that it is operating properly, and PM (Preventive Maintenance) be done on a regular (often annual) basis.