Re: What is the Difference between Laboratory-developed method and non-standard metho
If you go into FDA mode, you are way safe.....
ISO/IEC 17025 is not as intensive.....a standard method is like ASTM or similar, that is, published and accepted.....non-standard is a method that is not a published method and may or may not be developed by the lab.....lboratory developed is a method that is developed by the lab.....and a standard method used outside its scope is essentially the same as a non-standard method.....
Non-standard and laboratory developed methods both require validation.....a standard method used outside its scope requires validation of the usage.....the validation must be appropriate to the intended usage and must include a statement to the effect the the method is appropriate to the intended use.....
Now, as to the exact method to validate.....there is some flexibility there.....an entirely new method that is substantial obviously requires a fairly intense validation.....a minor expansion of a standard method may require only minor efforts to accomplish the validation including documentation.....
I usually suggest sending a validation plan to management, outlining the reasons to perform the validation, what the expected results are, what resources are needed, and what the timeline is expected to be.....then a report at the end matching inputs to outputs (expected to actual results), what resources were used, and a statement that the validation shows that the method is fit for the intended use (or not, if the validation shows that), and have management buy off on it.....
That meets the 17025 requirements.....
Hope this helps.
Hershal