Which way, validation or verification?
Here is our scenario;
In our lab , we prepare 1% Mayers hematoxylin staining solution in house from the following commercially purchased ingredients
- Ammonium alum
- Chloral hydrate Hematoxylin powered
- Citric Acid
- Sodium Iodate and
- distilled water
Based on the above information's should we conduct validation or verification?
Comments
In my knowledge , If we desire to illustrate nuclear detail in cells no need of validation , conduct verification only . But if we intended for new procedure that has no validation data , we expect to conduct validation followed by verification ,
Yes am tempted to go for verification but the the ingredient do not come with and any specified information for demonstrating nuclear details that we can verifies .
All new Test method and its elements, as long as it comes with its own processes should have validation and verification done I think... Dont you think so?
Perform method verification for new test methods/procedures or a machine but validation if you want to compare two or more test methods/procedures of same or different equipment
Awad, I agree with your submission.
You mean we should conduct both?
Alright but in this case the Hematoxylin which we use in combination with Eosin for tissue staining its not new its been there but never validated or verified .
Yes me too
Thank you Isack and for those who shared their thoughts. I will share the principles mentioned in the standard ISO 15189:2022. during the office hour.
Validation
Is the process of confirming through provision of objective evidence that a product, service, or test method has met the requirement for which it was specifically intended. Validation is done on non-standard methods, in-house developed and/or modified methods or those used outside their intended scope.
Verification
Is confirmation through provision of evidence that specified requirements have been fulfilled? Independent verification is therefore done on already validated procedures without any modifications.
Thanks
Do verification