Glossary
Water System (Pharmaceutical Water System)
The whole installation that produces, stores, and delivers pharmaceutical water to the points of use, requiring design, qualification, and continuous monitoring together.
Details
What is in scope is not the specification of the water but the whole installation that makes and delivers it, with the purification units, storage tank, and distribution pipework assessed as one. The corpus repeatedly cites the system used without being qualified, microbial contamination not tested at appropriate intervals, the system not designed to deliver water fit for the intended use, and no confirmation that the operating state was being maintained. Look also at dead legs and flow velocity in the pipework, the sanitisation interval, and the records of what was done when a limit was exceeded.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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However, you failed to adequately qualify your water system to ensure that the system is operating properly and continuously producing water suitable for…
FDA · FDA Warning Letter · 2024-09-24 -
Your water system is not adequately qualified, controlled, maintained, and monitored to ensure that the system is operating properly and continuously…
FDA · FDA Warning Letter · 2024-05-14 -
Based on the records and information you provided, you failed to demonstrate that your (b)(4) water system is adequately monitored to ensure that it consistently produces water suitable for use in the manufacture of APIs intended for further processing into sterile drug products.
FDA · FDA Warning Letter · 2026-05-19
