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Production of raw materials in university labs?

#11
Certainly, the legal mfr will want to ensure process and material controls are in place for your laboratory. I suspect your legal manufacturer has identified a Notified Body (NB) to get their QMS certified. To totally lock your strategy down, consider routing your question through your legal manufacturer responsible for the product who can consult the NB.
That hits the nail on the head for me - we cannot produce the device without ISO, even for clinical trials, so the manufacturer (for the time being a CMO we hired that has 13485) will bear the responsibility for assuring compliance as they assemble the finished device. I will ask them what they need to see to "ensure process and material controls are in place" regarding our component product.

Many thanks for your time and input - I´ll post a follow-up when I get the answer from our CMO.
 
#12
There are labs and there are LABS. How structured is this lab? Puting the legal aspects aside for a minute, your words in the original post are telling: cost-cutting. Some of the BIGGEST BLUNDERS in the business world, some that lead to hundreds of fatalities can be traced back to "cost-cutting good intentions".
Indeed. The lab is an academic research lab with all that comes with it. There is no way it can produce GMP-grade materials or survive an ISO audit, but the chemist is of the opinion that an outside testing lab can provide a CoA for material produced therein and if it comes up to scratch then we do not need to worry as the manufacturer will check compliance. He may be right, but I am missing the traceability aspect in this and the idea of defaulting on quality management cannot be good.

Thanks for the warning too - I fear such a procedure would seriously damage the reputation of our own company before we are in the position to offer ATMP developers our device.
 
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