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Hi Folks,
I needed some help here. My company is manufacturing Class ii medical devices and I was being task to write SOP or perhaps work instruction for design transfer to production (supply chain manufacturing).
Yet, I am getting confused when I was told to write about the procedure of design transfer to production which include New Product Introduction as well as initial production lot in manufacturing upon receiving all spec required from R&D (BOM, drawings, spec). In the same SOP/WI, CFR 820.70 (production and process controls) requirement must also be included. And finally, procedure about DMR is released to production.
I'm from engineering department and I don't really have in depth knowledge to write Quality related document especially regulatory topic like design transfer, DMR etc
Have anyone ever wrote such a SOP about design transfer, new product introduction and PnPC in one document...? Or should the topic be written in separate SOPs instead of one?
Any examples can share?
Thanks for the help.
I needed some help here. My company is manufacturing Class ii medical devices and I was being task to write SOP or perhaps work instruction for design transfer to production (supply chain manufacturing).
Yet, I am getting confused when I was told to write about the procedure of design transfer to production which include New Product Introduction as well as initial production lot in manufacturing upon receiving all spec required from R&D (BOM, drawings, spec). In the same SOP/WI, CFR 820.70 (production and process controls) requirement must also be included. And finally, procedure about DMR is released to production.
I'm from engineering department and I don't really have in depth knowledge to write Quality related document especially regulatory topic like design transfer, DMR etc
Have anyone ever wrote such a SOP about design transfer, new product introduction and PnPC in one document...? Or should the topic be written in separate SOPs instead of one?
Any examples can share?
Thanks for the help.