Validation Method Requirements - 21 CFR Part 820

B

biogic

#11
Hi Ronen,

Sorry for the confusion, the document I was referring too was in another response.

My frame of reference for method validation relates to the verification activities that we use during our process validation and ongoing process monitoring. In other words, how do we validate the tests that we use to validate our product and processes?
Perhaps their are no guidances specifically written for our circumstance and your suggestion of using the guidance provided for drugs and biologics would be prudent.

Thanks
 
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R

rjhill

#12
I work at a medical device company. We use no analytical test methods, we build electro mechanical devices. However, we have been challenged by FDA on this topic. My experience with them is that the expectation is that we have proof that our "test methods/test procedures/measurements" produce reliable answers. We have taken this to mean the test procedures
(test methods) we use to collect data, whether a measurement as part of a design verification test, a measurement used in process validation, or a measurement performed on the product at final QC, need to produce an answer that is reliable.

In my opinion, most of our measurements are direct (physical dimensions, tensile force, electrical resistance) and can be performed with general lab equipment designed for that purpose. These are calibrated so the accuracy, precision, bias... sections of TMV are taken care of. When we are using them in a way they were not intended - like using the resistance of a fluid to determine the purinty of fluid - the calibrated instrument may be accurate, but where is the proof that the purity of the fluid is being reliably determined? This is what TMV would provide.

Now, if we are using a piece of test equipment that we designed in house, we must now verify all the elements of TMV.

One other element we review for apparent straightforward measurements is if it is easy for the person performing the measurement to influence the result. Example, the operator's ability to use an optical comparator for precise measurements in a room with no ability to reduce the ambient light - how consistently can he repeat his measurements, and can they be be replicated by another person using the same optical comparator? Gage R&R (a part of TMV) can take care of this.

Because to the lack of guidance we have endless discussions on this topic; Quality Engineering leans toward TMV on every measurement, Product Engineering leans towards only doing a TMV on custom measurement equipment.

From consultants I have spoken to on this subject - be able to defend you test measurement results. That is, if you did not perform a TMV - why not?
 
B

biogic

#13
I work at a medical device company. We use no analytical test methods, we build electro mechanical devices. However, we have been challenged by FDA on this topic. My experience with them is that the expectation is that we have proof that our "test methods/test procedures/measurements" produce reliable answers. We have taken this to mean the test procedures
(test methods) we use to collect data, whether a measurement as part of a design verification test, a measurement used in process validation, or a measurement performed on the product at final QC, need to produce an answer that is reliable.

In my opinion, most of our measurements are direct (physical dimensions, tensile force, electrical resistance) and can be performed with general lab equipment designed for that purpose. These are calibrated so the accuracy, precision, bias... sections of TMV are taken care of. When we are using them in a way they were not intended - like using the resistance of a fluid to determine the purinty of fluid - the calibrated instrument may be accurate, but where is the proof that the purity of the fluid is being reliably determined? This is what TMV would provide.

Now, if we are using a piece of test equipment that we designed in house, we must now verify all the elements of TMV.

One other element we review for apparent straightforward measurements is if it is easy for the person performing the measurement to influence the result. Example, the operator's ability to use an optical comparator for precise measurements in a room with no ability to reduce the ambient light - how consistently can he repeat his measurements, and can they be be replicated by another person using the same optical comparator? Gage R&R (a part of TMV) can take care of this.

Because to the lack of guidance we have endless discussions on this topic; Quality Engineering leans toward TMV on every measurement, Product Engineering leans towards only doing a TMV on custom measurement equipment.

From consultants I have spoken to on this subject - be able to defend you test measurement results. That is, if you did not perform a TMV - why not?
Thank you for relaying your experience and some great advice.

Much appreciated
 
S

Sybarite

#14
With regard to your specific question. If you modify the method, you should have at least qualified that using a different instrument does not impact the accuracy or precision of the assay.

Food for thought.
To the OP, this is probably your easiest solution. Your reagent/kit manufacturer will have certain claims around linearity, precision, accuracy, etc... and the burden to prove that those claims are reproducible with your custom method lies with you.

If you are using less than the method's full range, or require less precision/accuracy for your purposes, then you can design a validation or verification that proves your custom method at least satisfies your needs, if not meets the original method's full claims.

The take-home message is that ALL methods that are used for verification/validation/acceptance must be validated methods, whether the manufacturer or the end user conducts the validation.

Hope this helps.
 
R

rjhill

#15
My company interprets the CFR as any "test" that is used to make a quality decision needs validated (testing involves measurement or qualitative assessment). Therefore formal verification tests, QC tests, QC cosmetic assessments, and measurements made as part of process validation are all measurements or assessments that need validated.
 
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