Management of Outsourced QC?

[KarenA01]

We are a small company which is both 13485 and ISO9001 (both fairly recently). We don't actually make devices but are producing biologics that could be used components in IVD kits or in the manufacture of things like vaccines or could be used in research.

Originally we did plan to develop our own products and do QC in-house... To that end I created all the primary QC framework SOPs including Sample submission, Analysis training requirements for demonstrating competency, Data Review procedures, Laboratory Investigation of OOS, Method validation etc.

But that is not how we evolved... We wound up doing contract manufacturing and all the "release" testing was done by the customer so we have not had an active QC group and only did some informal informational in process testing, although by the org chart my position is defined as Director Quality -QA/QC (Most of my career has been as an and R&D Analytical Chemist)

But we have continued to evolve...
Now we are in the process of developing our own products for which packaging and QC (including stability studies) would be outsourced. We envision the contract manufacturing becoming a smaller and smaller part of our business.

The vendor we are outsourcing to would do the analytical method validation as well as running the release assays and likely sampling... The vendor we plan to use for these services is both 13485 and cGMP (they have been inspected by the FDA) so their quality system should cover OOS investigations etc...

Every place I had previously worked did the product specific QC assays in-house and only outsourced the more "generic" type assays...

So my question is in this situation what to we need in terms of a QC "department", functions and SOPs and reporting in house? Does it need to be distinct from QA?


Thanks,
-Karen

 

[Jen Kirley]

I see no reason to have a QA Department if the responsibilities and authorities are appropriately defined, communicated, resourced, carried out and verified by competent persons.

 

[KarenA01]

I see no reason to have a QA Department if the responsibilities and authorities are appropriately defined, communicated, resourced, carried out and verified by competent persons.

Do you mean QC? I believe an independent "quality unit" that approves release is required and that is typically QA.

 

[Jen Kirley]

Karen, I am worried I misled you, but my laptop battery just ran out so I will need to wait a bit before reviewing my copy of 13485 and trying again with a better answer.

 

[Jen Kirley]

Do you mean QC? I believe an independent "quality unit" that approves release is required and that is typically QA.

Hi Karen,

I just reviewed 13485 again, specifically 8.2.6 and see no reason why a QA department, or even designation is required for release.

 

[Enternationalist]

It sounds like some language might be getting mixed up here. I see you talking about quality assurance units - that sounds like GLP language to me (21 CFR 58.35). From what you've described to us, I don't believe that would be applicable, but depending on your company's history (or your employment history), maybe some of those conventions were carried over. If you were a GLP facility, then it makes sense to have a specifically designated quality assurance unit.

But it doesn't sound like you are - 13485 is pretty clear. It doesn't ask you for specific departmental descriptions, it just has a list of things it tells you to do. You need to identify the person releasing product (and the other requirements imply that person needs to have adequate competency to do so), but it doesn't constrain departments or anything like that.

Do what makes sense for your product.