
Hi Ronen, always feel good to ask you the Question:
We do contract manufacturing ideally repackaging bulk Class IIa non-sterile products in pharmacy display boxes. We have controlled environment, but not a clean room. In the TF I have risk analysis of those products received from the manufacturer.
At what level I should conduct my risk analysis?
Can I just write a plane risk management report and state possible risks and applied control?
How much importance I need to give to determine overall residual risk assessment?
Cheers
Nash
Contract manufacturing = the devices are not sold (labelled) under you company's name, right?
In most leading regulatory domains, that would mean you are not regulatorily required to hold your own risk management files. USA regulation has some exceptions to that rule, but I assume you're not referring to sales in the USA, right? Look in the contract you have with this client - if it doesn't state any obligation re. risk management, then you can pretty much do whatever you think best serves the business.
From a regulatory perspective, the overall responsibility for risk management lies with the legal manufacturer (and/or the sponsor, in Australia). They may need / desire your contribution to this process, however it's still their own responsibility. If you are aware of any significant risks, it would naturally be the right thing to let them know about it, regardless of any hard obligations or explicit requirements.
Cheers,
Ronen.
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