Purified Water (PW)

Details

If a pharmaceutical water system is the equipment, purified water is the water quality grade that equipment has to deliver. The feed water must at minimum meet drinking water standards, whatever purification method is used has to be qualified, and the water follows the pharmacopoeial chemical and microbiological purity specifications. The corpus includes purified water that did not meet its microbial specification, purified water used as a component of the product with inadequate control of the equipment, and poor temperature control in the purified water generation area. What is examined is not only the test result but whether the point at which the sample was taken represents the actual point of use.

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Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Pharmaceutical water must meet the Purified Water USP monograph, be suitable for its intended use, and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.

   FDA · FDA Warning Letter · 2023-03-14

2. Your firm uses PW as a component to manufacture your drug products.

   FDA · FDA Warning Letter · 2022-08-16

3. In Unit A (building A), the water quality of the purified water (PW) does not meet the specifications for microbial contamination (<100 CFU/ml) for purified water, which poses risks to animal safety and public health.

   EMA · EU GMP NCR (EudraGMDP) · 2026-04-21

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.