Production and Process Control Procedures when you outsource your manufacturing

Kris215 · Mar 26, 2024

Hello,
I have been asked to establish production and process controls in compliance with the QSR. I am a little confused on how this works when you outsource your manufacturing for your products. If we manufactured our products we would have written procedures in place to maintain and control these processes. But when you outsource, if you put in your supplier manual that manufacturers must be compliant with QSR as one of the criteria for accepting them on your ASL then, are you covered?
Please help, I am new to the world of regulations in general.

Thanks,

yodon · Mar 26, 2024

You're getting warm.

You posted in the FDA forum so I presume you're ONLY distributing in the US? If so, they will need to be registered with the FDA for the product.

In general, it's good if they are certified to ISO 13485 for the scope of manufacturing you'll be having them doing. (If so, it's best to make sure it's through an accredited registrar ... and do check to ensure the scope covers your needs.)

You'll also want to execute a quality agreement with them.

It would be best (some might go so far as to say it's required), as part of your qualification and approval process, to (have someone qualified) conduct an on-site audit, focused on the activities they'll do for you.

Ultimately, it's your responsibility to confirm they have the proper production and process controls to make your device. The above are the means to get there.

Kris215 · Mar 26, 2024

yodon said:
You're getting warm.

You posted in the FDA forum so I presume you're ONLY distributing in the US? If so, they will need to be registered with the FDA for the product.

In general, it's good if they are certified to ISO 13485 for the scope of manufacturing you'll be having them doing. (If so, it's best to make sure it's through an accredited registrar ... and do check to ensure the scope covers your needs.)

You'll also want to execute a quality agreement with them.

It would be best (some might go so far as to say it's required), as part of your qualification and approval process, to (have someone qualified) conduct an on-site audit, focused on the activities they'll do for you.

Ultimately, it's your responsibility to confirm they have the proper production and process controls to make your device. The above are the means to get there.

Thank you for the response, that was very helpful. If you want to add any other guidance for someone new to the field please go ahead.

Production and Process Control Procedures when you outsource your manufacturing

Kris215

Registered

yodon

Kris215

Registered

Similar threads