M
melissa87
Hi,
We make ECG machines. Different manufacturers build different components of the machines like printed circuit board, boxes etc.
We want to assemble, test, package and ship the machines from our facility. we have not done that before. We got our registerion with FDA as a manufacturer recently. But our suppliers are not registered with FDA.
We have got one room about 50 feet x 50 feet, in which we want to establish the assembly area.
Questions:
1. I read CFR 820 Subpart G - Production and Process Control but was unable to determine how should I layout the room according to FDA's guidelines.
2. DO I need a SOP for this? If yes, can I get a sample or template?
3. When FDA comes for investigation. Will they also want to investigate our suppliers and how did suppliers build all the components for us? Our suppliers are spread all over USA.
Thanks
Melissa
We make ECG machines. Different manufacturers build different components of the machines like printed circuit board, boxes etc.
We want to assemble, test, package and ship the machines from our facility. we have not done that before. We got our registerion with FDA as a manufacturer recently. But our suppliers are not registered with FDA.
We have got one room about 50 feet x 50 feet, in which we want to establish the assembly area.
Questions:
1. I read CFR 820 Subpart G - Production and Process Control but was unable to determine how should I layout the room according to FDA's guidelines.
2. DO I need a SOP for this? If yes, can I get a sample or template?
3. When FDA comes for investigation. Will they also want to investigate our suppliers and how did suppliers build all the components for us? Our suppliers are spread all over USA.
Thanks
Melissa
