21 CFR Part 111 - Requirements for Dietary Supplement Manufacturing Water Quality

Q

qa2675

#1
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!
 
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v9991

Trusted Information Resource
#2
Select the set level of requirements based on the extent of exposure/usage of water in your manufacturing process.

in the meanwhile, following are suitable ref...

Q&A on DS....
Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Small Entity Compliance Guide

What does the DS CGMP rule require regarding the water supply when the water does not become a component of a dietary supplement?
The DS CGMP rule requires you to 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.
(21 CFR 111.15(e)(1))

What is an example of water that does not become a component of the dietary supplement?
Water used to wash floors does not become a component of a dietary supplement.
(72 FR 34752 at 34816)

What does the DS CGMP rule require regarding the water supply when the water may become a component of a dietary supplement?
The DS CGMP rule requires that, at a minimum, water used in a manner such that the water may become a component of the dietary supplement comply with applicable Federal, State, and local requirements and not contaminate the dietary supplement.
(21 CFR 111.15(e)(2))

What are examples of water that may become a component of a dietary supplement?
Examples of water that may become a component of a dietary supplement include water that contacts components, dietary supplements, or any contact surface.
(72 FR 34752 at 34816)

What steps should I take if I use a municipal water supply?
If you use a municipal water supply, you should take steps to ensure that you are at all times aware of problems, such as an acute problem with microbial contamination or a long-term problem associated with lead pipes present in some parts of the city water supply, that may not be reflected in the municipal water report.
(72 FR 34752 at 34821)

What does the CGMP rule require regarding water from a private source, such as a well, used in a manner such that the water may become a component of the dietary supplement?
The DS CGMP rule requires that water from a private source, used in a manner such that the water may become a component of the dietary supplement, comply with any State and local requirements and not contaminate the dietary supplement. Satisfying this requirement may involve performing appropriate water treatment procedures, including filtration, sedimentation, and chlorination).
(21 CFR 111.15(e)(2); 72 FR 34752 at 34817)

<1231> WATER FOR PHARMACEUTICAL PURPOSES

this is also outlined in another ref...
WHO good manufacturing practices: water for pharmaceutical use1


just in case if you haven't already seen them...
 
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