Hi all,
I would like to know to which part of 13485 this refers.
Say you make an anesthesia formulation. If you produce it you want the formulation to be correct of the materials that go into the formulation.
So on production you make a record of the materials that go into it, volumes etc and signoff for correct production and possible review of it.
In short you want to have evidence that the formulation of the product is correct and can be used.
To which part of the 13485 does this relate? Record control in combination with production process risk assessment?
I would like to know to which part of 13485 this refers.
Say you make an anesthesia formulation. If you produce it you want the formulation to be correct of the materials that go into the formulation.
So on production you make a record of the materials that go into it, volumes etc and signoff for correct production and possible review of it.
In short you want to have evidence that the formulation of the product is correct and can be used.
To which part of the 13485 does this relate? Record control in combination with production process risk assessment?