During HPLC analysis I realized that i don’put a vial (for rsd% areas).
After one day, Ca I re-inject the vial missing?
Without opening any investigation?
Nope! The run is invalid! Don’t be surprised if you get chewed out by the supervisor/manager.
But there is a normative reference that says this?
So I have to throw an analysis of 88 vials (each vial lasts 50 minutes !!!)
None that I have seen. Do you seriously expect a reference banning incompetence?
A careless mistake can not be considered “incompetence”.
I was tired after 13 hours of work
A double shift or being tired is contrary to labor standards (check them out in your jurisdiction). You fell asleep at the switch and let the train crash (or a tired surgeon leaving something in the wound).
no you can not.Did HPLC system shout down?Waters Alliance HPLC systems are shouting down if there is missing vial.
Question is not clear, There were plenty of instances would be experienced for VIAL MISSING.
- Which vial you have missed? I mean System Suitability Vial, Std., Sample and Bracketing or closing Standard vial.
I came to know that you have started with big injection sequence where, in which vial you have missed.
This is not a big issue or offence in industries which may happened due to inadvertent human error but it should be justified from preventing Regulatory people eye raising.
In this scenario you just make Impact assessment to derive the conclusion what actually you needs to do.
As a Standard (Do not ask any Guideline Reference, its just strike from wisdom only) you shall have some document evidence that you have invalidate the entire sequence or during the run you have inserted the vial. If you do not document that may be lead to Laboratory Incident.
Depending on your company policy just raise an Incident or deviation and get the root cause and start the analysis once again.
Pulla Reddy Karnati.
I personally (If I were QA) ask that the vial be tested and collected for information only (again depending on what this vial was, a statistic sample for in process data, system suitability, daily verification, etc.). I don’t think you can throw away the vial now, or else it might indicate that you were willingly/knowingly throwing away data (which is a big no-no). I would open an investigation as to why the sample was missed and put in place a corrective action so that it won’t be missed again. Then I would assess what the missing vial means to the data set, and whether the lot or data set can be salvaged - I would use statistics to back up any impact which states that the data point can be somehow thrown away, or not used in the data set.