GC-MS / GC-FID - Verification / Validation

Question

Hello everybody, 
 
 I operate an Agilent 7890B-GC/5977A-MSD and a 7820A-GC-FID, both with autosampler. 
 Those systems are yearly maintained by Agilent. 
 So far, GC-MS is for qualitative analysis (compounds identification through library search for normal injection and HS-SPME) and GC-FID is used for quantitative analysis through a multiple point internal standard method. 
 We are certified ISO-9001 but not ISO-17025. The analysis performed are for internal use only. 
 
 I have been asked to propose a routine check of the systems for QC. Basically to show that they are working fine. 
 Since I am not sure what kind of tests should be performed for this purpose, I would like to ask your opinion. 
 At first, it does not have to be too fancy. It will improve with time. 
 As for GC-MS, we were thinking about providing regular autotune / tune evaluation reports. 
 For GC-FID, I have no idea if a report can be generated for this purpose. 
 
 Thanks a lot for the help.

wcody · Accepted Answer

It sounds like what you need to implement is some type of system suitability test for each instrument. If you don't have a starting point I recommend looking up the guidelines for system suitability in the USP (US Pharmacopeia). The basic idea involves injecting a standard multiple times to demonstrate detection sensitivity, resolution, and reproducibility. Ideally the standard will represent the testing being done by the instrument by both type of compounds and the method parameters. 
 A tune is fine and may give an idea of the sensitivity of the detector, but a tune won't let you know the phase of your column is worn out and needs to be replaced, or the inlet liner is contaminated and needs replacing.

james_jenkins · Answer

As Wcody suggested , system suitability maybe all that is needed. If the need goes beyond that, Agilent does offer an Operational Qualification that could be performed on a yearly bases. The Qualification comes with documentation that can be reviewed by auditors. 
 Regards 
 James

GC-MS / GC-FID - Verification / Validation

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