Validation Requirements for Contract Manufacturers

GOOD VALIDATION PRACTICE (cGVP)
1

We have contracted manufacture of some product to a vendor but our facility is ultimately releasing the product to distribution for sale. To what degree are we expected to validate the contract manufacturer?

2

First off, you wouldn’t validate the CM. You would only approve based on your criteria.

I can only speak for the medical device industry (other regulated industries may be different), but you would identify the processes whose results aren’t 100% verified and then validate them. It’s a much longer story involving risk management, etc., but that’s the gist.

3

Ok - I didn’t mean validate them in the strictest sense but aren’t we obliged to ensure that they qualify their equipment and validate their processes to the required standards?

4

Dear Fiona,

I can only speak for our local authorities, but I don´t think there is a much different approach in other countries. As the product owner, we are held responsible for the quality of the product, regardless where it is manufactured, and thus we are responsible for the process and cleaning validation and the equipment and utility qualification as its precondition, at the contract manufacturer.

  • Equipment and utility qualification: In our case the contract with every toll manufacturer includes a clause which states his responsibility for the equipment qualification and the inclusion of the product owner (us) in the change control communication circuit.

  • Process validation: It is included in the contract as a shared responsibility, but as a matter of fact it is carried out by the product owner because it is too much hassle to go through the analytical method transfer to the toll manufacturer only for the process validation. Some activities (sampling, process records, etc.) may be carried out by the toll manufacturer.

  • Cleaning validation: It is the responsibility of the toll manufacturer to keep his product matrix updated and included in the change control system, the definition of the sampling points in the equipment, and the development of a cleaning method, but the cleaning validation is carried out by the product owner, again because of the analytical method transfer. In the contract we have a clause which obliges the toll manufacturer to disclose all the chemical entities manufactured in the equipment shared with our product, which leads to a lot of discussion.

Again, this is our local approach, but it may give you some hints.

Best regards

Alfred