Chromatography Forum

We are a medical laboratory that has introduced the three machines for clinical patient analysis:
1- ICP-MS
2- HPLC
3- Amino Acid Analyzer

CAP accreditation demands that, these machines are validated for the methods before being used to analyze and report patient results. Does anybody have a procedure for validating these machines for:
1- Precision
2- Accuracy
3- Linearity and AMR
4- Specificity
5- Sensitivity
6- Etc.
Could you please give us a reference which can help us develop the validation procedure? Thank you.

See ICH guidlines Q1 for validaiton of analytical methods. The parameters you need to look at depend on teh type of analysis e.g. determination of impurities, or determination of bulk components such as the active material (i.e. things you expect to find).

Actually you're not supposed to validate the machines, but the methods. The appropriate guideline to consult is actually ICH guideline Q2, not Q1 (Q1 is about stability testing).
However, the machines themselves need to be QUALIFIED. Decent IQ/OQ/PQ should be done (that's Installation, Operational and Performance Qualification). You've taken care of this? No sense in validating and running methods on machines that are not properly qualified...

Presuming your testing will be to support clinical trials then the ICH document referenced above, and these two should eb a starting point

http://www.fda.gov/downloads/Drugs/Guid ... 070107.pdf

http://www.ema.europa.eu/docs/en_GB/doc ... 109686.pdf

If you are doing diagnostic testing (i.e testing a patient sample to diagnose the patient, in a hospital or clinic perhaps), then I'm not sure what regulations would apply, but this might be a start

http://www.iso.org/iso/home/store/catal ... mmid=54916

Paul.

The appropriate guideline to consult is actually ICH guideline Q2, not Q1 (Q1 is about stability testing).

Busted! I have Q2R1 here hence the typo. As said, you should qualify the equipment separately from validating the methods. The manufacturers may have some standard test conditions you can use.

Thank you all Guys. I have to take a look at all the documents referred to by all to see which will satisfy the objectives of our analysis.

Chromatographic kits are from Chromsystems, and Biorad