QA involvement with Quality Agreements for Outsourced processes


Involved In Discussions
We are a small company transitioning from being a CMO to producing our own products and are newly 13485 as of last spring.

The type of CMO work we were doing was to produce bulk "raw" biological materials that the customer further processed. The release testing was done by the customer.

For our own products we would then purify and have the the final product vialed for sale to end users...
The parts of the process we intend to outsource is the vialing/kiting and the QC release testing... We would label such product for research use only.

We have never outsourced any part of our production processes before and have no experience doing so. By the standard we need to have a quality agreement with the vendor of these services (plan to use the same one for both and they are 13485 and cGMP).

My question is who typically negotiates such quality agreements with the vendor, and what is the typical QA role in it? Is it more than review and signoff of the final agreement? (I assume it is at least that)



Trusted Information Resource
Hi Karen,

Usually start off with a responsibility matrix to document who is responsible for each activity.
QA plays a role in reviewing the agreements, but usually someone from Purchasing often takes the lead.
Most companies have a template for the agreement that they tailor for the situation.



Quite Involved in Discussions
I'm not so sure that there is any "typical" QA role as it depends on the product and what is being outsourced. Also, is the QA Function looking after Regulatory matters as it is a small organization or do you have a separate Regulatory Affairs (RA) function? All aspects of what is required for QA/RA need to be reviewed appropriately to ensure that full compliance will be maintained. For example QA may wish to look at any equipment calibration process/procedure associated with the subcontracted processes, is any inspection/test equipment to be used by the subcontractor appropriate and can measure to the required accuracy (or will you be supplying it, in which case who will be responsible for calibration). There is also the consideration of training and experience of the subcontractor's staff to perform the processes required for you - what evidence can the subcontractor provide to you, maybe your organization will have to train some of the subcontractor's staff to perform specific tasks, maybe you will have to review and approve their internal work instructions etc associated with the work that they will be performing for you.

How are you going to verify that the outsourced processes meet your requirements on a consistent basis?


Quite Involved in Discussions
Orgs will vary. Typical players are Quality, Supply Chain / Purchasing (whatever name they go by) and Legal. In orgs I have been most involved in, Quality takes the lead.
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