Hello Elsmar Colleagues. I've been asked to perform a task within a role I'm a bit new to, and quite honestly I'm not sure how to approach it. I could use some some guidance, if willing.
In short, my US based company outsources manufacture of a drug-device combo currently being used in Clinical Trials in the EU. We contract with a US based ISO 17025 registered lab who performs Design Verification Testing of the prefilled syringe devices for us.
The QP responsible for signing off on the GMP compliance statements attached to the drug application, has requested we provide a document that specifically states this lab meets EU GMP Compliance.
I've gone through the companies Quality documentation and there are no references made to conforming to ICH guidelines or directives. They have a QMS that's established, implemented, and maintained to ensure both compliance to ISO 17025 and the quality of calibration and testing results.
Is this perhaps an exercise where I go through the elements of their QMS and see if I can match them up to specific line items in the ICH guidelines/related directives?
Thank you in advance for all advice. Happy Friday!
In short, my US based company outsources manufacture of a drug-device combo currently being used in Clinical Trials in the EU. We contract with a US based ISO 17025 registered lab who performs Design Verification Testing of the prefilled syringe devices for us.
The QP responsible for signing off on the GMP compliance statements attached to the drug application, has requested we provide a document that specifically states this lab meets EU GMP Compliance.
I've gone through the companies Quality documentation and there are no references made to conforming to ICH guidelines or directives. They have a QMS that's established, implemented, and maintained to ensure both compliance to ISO 17025 and the quality of calibration and testing results.
Is this perhaps an exercise where I go through the elements of their QMS and see if I can match them up to specific line items in the ICH guidelines/related directives?
Thank you in advance for all advice. Happy Friday!