Analytical Method Qualification Vs Validation expectations


Involved In Discussions
As I've mentioned before we are going for 13485 certification but we don't produce devices and are a small company...

We make enzymes/biologics via fermentation that once purified sufficiently may be used for inviro diagnostics or vaccine components among other things... So as a "component" supplier we know we are not required to be 13485, but we have been told from multiple sources that customer for such things strongly prefer their suppliers to be 13485 certified... So we are going for it (we got 9001early last summer)

Up until now we have been just been doing contract manufacturing and only producing cell mass which then gets shipped to the customer to extract the enzyme of interest that the the customer supplied organism has produced .. Very crude material...

The only spec is meeting a target wet cell weight... and the customer does the final acceptance testing... so until now we essentially have not had a QC function, just a simple in-process test.

But we are staring to develop our own products where we either buy or produce a clone yo me the enzyme, extract and purify it to some degree (though it may not be to the final purity required for the application above - more an industrial grade)... In any case anything we sell would probably say something like for research use only... meaning we would not take any responsibility for it's use for invitro diagnostics or vaccine use - that would be totally on the customer.

In any case having our own products would mean we need to set up a QC lab...

Now my background is Pharma Analytical R&D (not QC) and I had assumed that under 13485, as for GMP, analytical methods that determine strength, purity etc would need to be validated for use in product release...

The 13485 consultant we have isa electrical engineers by background, and even when their other customers worked with biologics, it was sounded like it was for their own in-vitro diagnostic products... In any case it was obvious they could not provide specific enough advice for our situation in some areas.

So we invited a QA Drector from one of our customers that has been 13485 certified for over decade to come over and discuss with us how to implement certain parts of 13485 in our situation... And they agreed...

That QA director said that they did not validate their analytical methods. They just "qualified" them and did repeatability and intermediate precision... He also said we did not have to do a lot of other things that we had to to in pharma production ... Basically justifying it with a risk based argument as they label their product as not for human use... It just seems so foreign to me.

So is qualifying release testing methods with just repeatability and intermediate precision likely to pass muster? If would think for any quantitation linearity would matter...

Also when I look up "qualifying" on line, it referred to early stage analytical methods, and from what I read it sounded like the analyte did not even have to be in the final matrix! I'm used to needing to do spike recoveries in the final matrix when possible!

What would qualification mean in his context?

I would appreciate some feedback ...



Involved In Discussions
I would still appreciate some feedback ;)

Section 7.5.6 of the standard says in part:
"The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement"

As our products (homogeneous batches of biologics sold by the entire batch) can and will be verified by testing, we won't need process validation... (except that the Design and development causes seem to require it.. - i'll ask about that in a other thread).

But then it seems obvious the testing methods themselves require some degree of formal "verification" themselves ... but what degree?

Top Bottom