Like-for-like critical raw material change qualification - type of testing/ number of lots required

[Jane's]

Hello,

What is your rule of thumb for steps to undertake when implementing a like-for-like change of a critical, custom raw material (candidate RM), assuming the new supplier of the material is on your approved supplier list?

I assume you would require the supplier to manufacture three or so lots of the critical RM and you would manufacture the component or product using that candidate RM (candidate product) the way you manufacture it with the previously approved raw material and perform release testing. Would it be sufficient to test the candidate product using your regular release testing or would you do additional testing to qualify the candidate RM?

Also, how about changing the supplier of the IVDD calibrator/ standard? Would that be different/ require more scrutiny than just release testing of a few lots of product?

 

[William55401]

Without knowing more about the material and how it impacts device performance, it is hard to answer. Given this, I agree that the product release testing is helpful. However, I am left wondering about tests that may be needed that are more typically part of pre-production design assurance such as biological safety or shelf life. Can you share more info about the material and where it is used?

 

[Jane's]

Hi there,

Thanks for your response. The IVDD standard or calibrator impacts the device performance to a great degree. The IVD device is used to diagnose an autoimmune condition by testing for presence and concentration of a biomarker in the patient serum.

Since i posted the OP, i did some reading and am for the most part comfortable with the type of testing I need to do. I still have one remaining question and that is the old dilemma - do i have to have three batches of a multi-component kit to validate the critical raw material change (validate meaning do the analytical validation - precision accuracy linearity, etc)? If it's best to have three for the statistical significance of the data, is there a hard reference i can show to my tight-fisted head of operations as the evidence for my claim? it's always hard to justify the high cost of quality testing but in some instances harder than in others.

Thank you for any thoughts you may have on this issue.

 

[asdfg]

Hi,

It is difficult to provide an answer with more information. Do you have any specific QC incoming tests? you could do the test with multiple components at the incoming level showing like by like with the original raw material. In principle the purpose of the incoming check is to approve material and once the raw material passes this test you have previously validated that it is fit for purpose within the full manufacturing process. You should carry this out with multiple lots of your new raw material and multiple testing reagents. Once you are satisfied your new raw material passes your incoming test, you can verify the effectiveness of the change with different lots of final released product. Some of these final product lots should be included in your shelf life programme to confirm stability in addition to performance at final release

 

[Jane's]

Your answer is pretty much what I figured. Thanks for this.