Can pharmaceutical companies delegate some responsibilities to supplier?

[W. de Jong]

Hi everyone,

Is it possible for pharmaceutical companies to delegate their responsibility, concerning the checking of raw/ starting materials, to the supplier?

We (a supplier) want to provide products conform Parmacopoeia. But if pharma companies are not allowed to do so, we would simply check our spec's according to the pharmacopoeia. (meaning: using different, non-pharmacopoeia methods)
Otherwise we would make a lot of costs and the manufacturer will have to do so all over again. Or maybe the manufacturer can perform a more simple test that will do. I don't know what the GMP or ISO13485 say about this.

Thanks in advance,

 

[Denis]

Need more information on the situation regarding the relaxation of inspection routines on incoming stock.

What raw materials are we talking about? what risk analysis has been performed to assess the impact of non conforming raw material on the finished product? if raw material is supplied and used will the supplier accept a consequential claim?

How confident are you in the supplier(s) ability to provide defect free material?

I too would like to go down this route, but the total reduction in any inspection routines would have to be clearly documented with quite a bit of evidence over a period of time. Comes back to the risk management, but some customers will be very wary of this practice and may put pressure on you to provide some form of reduced sampling plan.

 

[W. de Jong]

Hi Denis,

Thanks for your comments. In the meantime i've leaned that in our case it is possible. Currently the manufacturers are not capable of testing the goods themselves so they rely on the supplier. They do perform periodically third party tests for confirmation. This, besides the fact that it is not a very critical factor, takes the heat off this topic.

Sincerely,

 

[Statistical Steven]

If the Pharma company has in place the appropriate quality systems, they can delegate incoming inspection to a supplier. Ultimately, the pharma company is responsible for the quality, but if they audit the supplier appropriately, they can rely on supplier testing.

 

[W. de Jong]

Ultimately, the pharma company is responsible for the quality, but if they audit the supplier appropriately, they can rely on supplier testing.

Just what i needed to hear! Thanks!