Dear all,

I would like to have a better understanding of the difference between laboratory-developed method and non-standard method. Is it the laboratory-developed method is those method modify from standard method to be use only within their own lab? And the non-standard method is those method develop themselves from stratch and to be use for client?

Anybody can help me on this out there. Thank you

Look at section 6 of this .pdf file (www.fda.gov/ora/science_ref/lm/vol2/section/5_04_05.pdf) for an explanation, and section 7 for definitions.

I hope this helps!

I would like to have a better understanding of the difference between laboratory-developed method and non-standard method. Is it the laboratory-developed method is those method modify from standard method to be use only within their own lab? And the non-standard method is those method develop themselves from stratch and to be use for client?

You are correct, that is exactly the meaning under ISO/IEC 17025.....however, there is one additional part, that being standard methods used beyond their scope, that is, used in a manner not originally documented.....in that instance, then the new usage must be validated.

Don't forget, for laboratory developed methods, they must be validated. Talk to your accrediting body to find out their rules or protocols for validation.

You can find your accrediting body by going to

http://www.aplac.org

and finding the body for your country.

Hope this helps.

Hershal

Actually, a laboratory-developed method can also be developed from scratch.

Ok, this is an interesting thread, an I'm a bit confused (imagine that), so I'll pose a few more questions.

1. Like Jennifer posted, when I hear validation, I instantly go into an FDA mode. My experience has been these validation efforts are very formal and documentation-heavy. Do these validation resemble those efforts?

2. I read about "standard" method and "non-standard" methods. How are those identified?

I guess I'm asking for general suggestions as to how validation (in relation to ISO17025) is identified and completed.

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

Thanks a lot for your guys valuable information. Now i can a better picture on it.

Thanks.