I understand the confusion and it is a common one. I feel that the reason for the confusion is that often the same exercise does both. It is wise to still keep the two definitions separate to ensure you are achieving both, especially the validation portion.
Design: Verification Vs Validation And Validation Vs Transfer
- Thread starter KarenA01
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I understand the confusion and it is a common one. I feel that the reason for the confusion is that often the same exercise does both. It is wise to still keep the two definitions separate to ensure you are achieving both, especially the validation portion.
Many years ago when I worked for a department in very large corporation, we did exactly that when we were looking at automating information management activities.
The link does not work for me.
Thanks,
-Karen
In terms of the design development process (not routine batch manufacture), I am a bit fuzzy about the difference between verification and validation, as well as the difference between process and product validation...
Some years back when I was in Pharma, we had a different structure that made things clearer to me.
"Verification" really amounted to the Phase 3 clinical trial. But in addition we also had to show we could make the product reproducibly. Back then that was showing we could make 3 full scale batches in a row that passed all the lot testing requirements. (obviously one could not do clinical trials for each batch!)
I always personally thought of the 3 sequential lots that "passed' requirement as process validation... but I guess it could be considered product validation...
As I was in R&D and not Quality or Regulatory I don't know how it was "officially" viewed- just that we needed to do it...
Three lots in a row that pass (particualry if one uses a meaningful biological activity assay) seems to me to be a reasonable indication that you can reliably produce product that meets customer requirements (though it can be expensive at full scale)... but if it's a process validation it would not need to be done as we can just test final product....
So for developing enzyme products under 13485 which may be used as reagents for IVD (or for use in a step during vaccine manufacturing), what would be the practical difference between verification and validation in general terms?
Do we need to do something like the 3 sequential full scale lots to "validate" the product to meet the 13485 product validation requirement? If not then what?
Thanks,
-Karen
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Karen,
Then please try these links:
Getting started in ISO 13485
Getting started in ISO 13485
Getting started in ISO 13485
Getting started in ISO 13485
Getting started in ISO 13485
Getting started in ISO 13485
These are all the links that come from searching this site for developing management system and ISO 13485.
Best wishes,
John
Examples or analogies would help the imagination a good bit!
My "validation" experience has been for analytical methods... which in principle is a testing process validation ... and those testing methods then used to verify product and validate processes.
-Karen
I think It just dawned on me what the difference between verification and validation is... The terminology threw me off because I was not used to it and my mind it was basically doing the same thing!
It was alluded to by those posting here, but it was just not penetrating because it was so obvious... and something I have done without using such labels for decades...
It seems to be mainly a matter of when!
Verification is in the earlier stage before you finalize the product/process to make sure you are on the right track (and is the primary iterative part). In out case it would be one of the gating factors to scale up to go to the scale-up phase.
Validation is then essentially verifying product to final product specifications and functionality when made under the final "production" conditions/scale.
If validation will be more extensive then teh verification procedure , then verification of paducah at scale may then be done again before the "validation" or as part of it.
Validation and Verification may or may not use the same methods/tests...(use of phase appropriate methods)
Have I finally seen the obvious?
If my understanding now is correct, since we we can verify each batch, we don't need to do process validation just product validation.
In theory the "validation" of our type of products could only be the "verification" of one production scale lot against final product specifications (assuming that includes an activity assay and/or an evaluation of a the performance of a sample by a customer) as the 3 consecutive lot requirement is for process validation.
Doing only one validation batch ups our chances of failed lots, but it would be caught on release testing, so deciding to do more for validation would be purely financially risk based?
Is that right?
It seems to me there are some basic differences between device and pharma development, and although we need to get certified under 13485, what me make is physically closer to pharma in some ways than devices ..
But in other ways it's not like pharma, as what we make will never go directly into a patient , and although it may be used as a reagent in IVD kits, we would not be producing such kits (our customers would be)... and even for kits in some cases it would be a general reagent in some cases and in others it could be an analyte specific reagent...
-Karen
You are starting to see the light.
You are required to do design validation, as least whatever you can. Sometimes design validation is shared with the customer who may be better able to exercise the product in real world applications.
You are only required to do product validation when verification is not possible or economically feasible.
Different standard, but in AS9100 there is a certain type of verification of product called First article inspection. The requirement is to take a sample from the first production run and inspect it critically to ensure that the production documentation and equipment are capable of properly producing the part. Even though this is a different standard it may give you some insight about product verification.
You are required to do design validation, as least whatever you can. Sometimes design validation is shared with the customer who may be better able to exercise the product in real world applications.
You are only required to do product validation when verification is not possible or economically feasible.
Different standard, but in AS9100 there is a certain type of verification of product called First article inspection. The requirement is to take a sample from the first production run and inspect it critically to ensure that the production documentation and equipment are capable of properly producing the part. Even though this is a different standard it may give you some insight about product verification.
Examples or analogies would help the imagination a good bit!
My "validation" experience has been for analytical methods... which in principle is a testing process validation ... and those testing methods then used to verify product and validate processes.
-Karen
Indeed, alternate calculations and simulations are often part of a design validation activity.
