Test method validation on raw materials, intermediates and final device

J

jampot

#1
I was hoping for some advice concerning test method validation.

We undertake a series of QC tests (on raw materials, intermediates and final device) on a product currently in development and I am struggling as to how I can validate a number of these tests. Some are common such as pH, dimensions, FT-IR analysis whilst other are fairly product specific.

My question relates to how to go about validating some of these test methods. How would you validate a pH test. Do you approach it from a material/product point of view or the equipment perspective (I know how to calibrate a pH meter/probe but is this sufficient?) Another thing I am having difficulty with is how to validate the FT-IR analysis of a compound. In this instance linearity isn't an issue.

Any advice with this would be appreciated.
 
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Al Rosen

Staff member
Super Moderator
#2
jampot said:
I was hoping for some advice concerning test method validation.

We undertake a series of QC tests (on raw materials, intermediates and final device) on a product currently in development and I am struggling as to how I can validate a number of these tests. Some are common such as pH, dimensions, FT-IR analysis whilst other are fairly product specific.

My question relates to how to go about validating some of these test methods. How would you validate a pH test. Do you approach it from a material/product point of view or the equipment perspective (I know how to calibrate a pH meter/probe but is this sufficient?) Another thing I am having difficulty with is how to validate the FT-IR analysis of a compound. In this instance linearity isn't an issue.

Any advice with this would be appreciated.
The requirement is to validate your process. The tests are a means of verifying the process results. If you can verify the process through testing, you may not need to validate the process. Look at the GHTF Process Validation Guidance.
 

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J

jampot

#3
Dear Al,

Many thanks for your input.

I am struggling a little with the distinction between process validation and test method validation. We are undertaking process validation for one product manufacture and I think I'm happy with our approach (IQ/OQ/PQ).

It was my understanding that validation of the various test methods used seems to be a different area/requirement. By way of an example, we have validated the method to determine the presterilised bioburden of the device and this test this then rountinely used to verify than the bioburden of the final product is low/within limits. Another example is endotoxin determination.

A number of the QC tests are used to support the validation of the manufacturing process but I was led to believe that the method of testing also required validation. In a number of cases this has been completed, however there are some QC tests (pH of intermediate solution, appearance of final product, solids content of final product) that I am having difficulty with.

Many thanks
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
Jampot,

One question.....since you specifically mention the test methods, are you then a test lab that therefore needs accreditation under ISO/IEC 17025?

If yes, since you are in UK, contact UKAS and find out if they have specific requirements to validate a method.

Hope this helps.

Hershal
 
J

jampot

#8
Dear Hershal

We're not a test lab but you're right regarding advice from UKAS.
Thank you
Jampot,
 

Statistical Steven

Statistician
Staff member
Super Moderator
#9
Certain methods such as pH are considered compendial methods that do not need to be validated. As long as you use the USP method for pH, you only need to show that using WHO traceable standards, that your method is linear and accurate.

I draw your attention to ICH guideline Q2A, specifically the table on page 3. Depending on the use of the method, you might have a reduced testing scheme to validate the method.

Here is the Q2A reference http://www.emea.eu.int/pdfs/human/ich/038195en.pdf

This is an area I speak on often. If you have any questions, please do not hesitate to contact me.
 
D

ddouglas

#10
Does anyone have any experience documenting that your company has chosen not to perform test method validations?
 
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