Hi Everyone,
So my next question relates to GLP/GMP NMR.
At some point, I will need to run GMP samples on my "new" NMR. I had thought that it would be best to have the instrument installed as a GLP/GMP instrument with vendor software that would run the standard tests and determine suitablity for use. I also wanted to add the second tier of software after installation that allowed me to build libraries for specific products/raw materials (many!) and that would allow me to automate pass/fail of products.
If any vendor (manufacturer or third party) says he will prove complete IQ/OQ/PQ to meet 13485 as well as GLP installation - what do I look for to judge compliance to Standards (Medical Devices/Pharma) and traceability? What sort of certification should the vendor engineer provide as part of the documentation? Should the vendor have a Quality System in place and documented, controlled procedures to cover the installation/qualification? Any particular Standard that covers NMR as an analytical tool that I need to read/incorporate into the installation?
1. So if you are running a GLP/GMP NMR lab - how did you get started? did you dive in and do it old school or did you rely on vendor software/help?
2. If you could start from scratch again, what would you do differently?
3. For comparison purposes, how many GMP product/raw material protocols do you run per instrument in your facilities (not how many samples)?
Hate to bother you all. I hope that a few of you will take a little time to educate me.
Best regards,
MF Leopold
Life Technologies
mary.leopold_at_lifetech.com
Received on Wed Nov 14 2012 - 15:33:33 MST