21 CFR Part 129 - Processing and Bottling of Bottled Drinking Water

What it says

Plants that process and bottle drinking water must follow current good manufacturing practice covering plant and grounds, sanitary facilities, equipment, source water, processes and controls, bottling operations, and sampling and testing of source water and finished product for microbiological, chemical, physical and radiological quality. Records must be kept.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Source water quality is the starting point, so the source is tested and the water treatment is controlled.
• Finished product testing confirms that the treatment and bottling steps are working.
• Cleaning and sanitizing of bottles, closures and the filling line is an important control.

What FDA inspectors look for

• Whether source and finished product testing are performed at the required frequency.
• Whether treatment equipment is maintained and operating properly.
• Whether containers and closures are cleaned and protected from contamination.

Related regulations