Which statement correctly describes potable water requirements in GMP?

• A. Potable water that meets regulatory specs and is monitored.
• B. Use distilled water in all cases.
• C. Water quality is optional for cleaning.
• D. Water must be boiled every hour.

Answer: (A)

In GMP, water used in manufacturing, cleaning, or as an ingredient must be potable and meet regulatory specifications, with an active monitoring program. This means the water is treated to remove or limit microbiological and chemical contaminants so it cannot introduce risks to product safety or quality. Regular monitoring is essential—test points for quality include microbial counts, pH, conductivity, residual disinfectant, and possibly total organic carbon—so you can verify the water stays within defined limits and catch any system issues early. If water deviates from specs, actions are taken to correct the problem and prevent use until the water is back within acceptance criteria. Distilled water isn’t required in all cases, and cleaning water isn’t optional or something to be boiled on a fixed hourly schedule; the process requires water of an approved quality appropriate for its intended use, backed by documented validation and ongoing verification.