Q
qa2675
Hi!
I am making an SOP for water quality for a dietary supplement manufacturing company per 21 cfr 111. I think the requirements are similar to food manufacturing.
Does anyone know what are the procedures for purifying and testing water?
This is what the requirements say:
(e)Water supply.
(1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement.
(2) Water that is used in a manner such that the water may become a component of the dietary supplement, e.g., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement.
I would really appreciate it if anyone has a sample SOP.
Thanks!
I am making an SOP for water quality for a dietary supplement manufacturing company per 21 cfr 111. I think the requirements are similar to food manufacturing.
Does anyone know what are the procedures for purifying and testing water?
This is what the requirements say:
(e)Water supply.
(1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressure as needed, for all uses where water does not become a component of the dietary supplement.
(2) Water that is used in a manner such that the water may become a component of the dietary supplement, e.g., when such water contacts components, dietary supplements, or any contact surface, must, at a minimum, comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement.
I would really appreciate it if anyone has a sample SOP.
Thanks!