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Validation vs. Confirmation in the context of an Analytical Laboratory

B

Basem

#1
Hello every one
Would anybody please tell the difference between validation and confirmation.
thanks
 
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Stijloor

Staff member
Super Moderator
#2
Re: validation and confirmation

Hello Basem,

Before we get too carried away here: In what context are these words used?
What specific process are we talking about?

Stijloor.
 
B

Basem

#3
Re: validation and confirmation

Thank you for fast reply
In a test laboratory (food analysis), If we use international test method like ISO or EN standards should we validate it or confirmate it (what is the difference).
thank you
 
D

DsqrdDGD909

#4
Re: validation and confirmation

Do you currently use AOAC methods also?

From a google search...
"When is validation needed?
• Before introduction of a new method into routine use
• Whenever the conditions change for which a method has
been validated, e.g., instrument with different
characteristics
• Whenever the method is changed, and the change is
outside the original scope of the method
L. Huber (2001) Validation of Analytical Methods: Review and Strategy. Supplied by www.labcompliance.com"

and

Assumptions When Performing Validation
• The equipment on which the work is being done is
broadly suited to the application. It is clean, wellmaintained
and within calibration.
• The staff carrying out the validation are competent in the
type of work involved.
• There are no unusual fluctuations in laboratory
conditions and there is no work being carried out in the
immediate vicinity that is likely to cause interferences.
• The samples being used in the validation study are
known to be sufficiently stable.
Roper, P., et al. (2001) Applications of Reference Materials in Analytical Chemistry. Royal Society of
Chemistry, Cambridge, UK, pp. 110-111.
 
Last edited by a moderator:

Stijloor

Staff member
Super Moderator
#5
Re: validation and confirmation

Thank you for fast reply
In a test laboratory (food analysis), If we use international test method like ISO or EN standards should we validate it or confirmate it (what is the difference).
thank you
Hi Basem,

That's a little bit out of my league...I hope my Fellow Covers will respond to your question.

Covers in the Food Industry? Any takers?

Stijloor
 
B

Basem

#6
Re: validation and confirmation

Yes
We use AOAC methods now but without validation
Thanks
 

harry

Super Moderator
#7
Re: validation and confirmation

Thank you for fast reply
In a test laboratory (food analysis), If we use international test method like ISO or EN standards should we validate it or confirmate it (what is the difference).
thank you
Read this extract from ISO 17025 & GMP

EN ISO/IEC 17 025
Validation of methods (titration, UV/VIS, gravimetry, HPLC, GC)
Validation is the confirmation by examination and the provision of effective evidence that the particular requirements for a specific intended use are fulfilled.

The laboratory shall validate non-standardized methods, laboratory designed/developed methods, standardized methods used outside their intended range and amplifications of standardized methods to confirm that the methods are fit for the intended use.
GMP: ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology (CPMP/ICH/381/95)

Objective of validation of an analytical procedure is to demonstrate that it is suitable for the intended purpose.
Types of analytical procedures to be validated are:

* Identification tests.
* Quantitative tests for impurities‘ content.
* Limit tests for control of impurities
* Quantitative tests of the active moiety in samples of drug substance or drug product or other selected component(s) in drug product.
 
Last edited:
Y

Yew Jin

#8
Re: validation and confirmation

Hi Harry,

We are using the term of validation and verification.

From ASQ glossary,

Validation - The act of confirming a product or service meets the requirements for which it was intended

Verification - The act of determining whether products and services conform to specific requirements
 

harry

Super Moderator
#9
Re: validation and confirmation

Thanks Yew Jin. The definitions you gave are the generally accepted ones. For validation, if you substitute 'service' with provision of lab analysis and report and 'requirements for which it was intended' with ISO 17025 or GMP/GLP requirements then you get the exact definition of validation as found in ISO 17025. That's why in post #2, Stijloor asked for the exact context or process that the OP was referring to.
 
G

glyhkn

#10
Re: validation and confirmation

if you are using standart methods like ISO you do not need validation but you need to do verification.
That verification may include formation of control charts, controls of calibrated equipment you use (temperature checks for furnaces or checks of balances with certified mass)
 
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