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1.2.2 Control of the quality of water throughout the production, storage and dis-
tribution processes, including microbiological and chemical quality, is a major con-
cern. Unlike other product and process ingredients, water is usually drawn from a
system on demand, and is not subject to testing and batch or lot release before use.
Assurance of quality to meet the on-demand expectation is, therefore, essential.
Additionally, certain microbiological tests may require periods of incubation and,
therefore, the results are likely to lag behind the water use.
1.2.3 Control of the microbiological quality of WPU is a high priority. Some
types of microorganism may proliferate in water treatment components and in
the storage and distribution systems. It is crucial to minimize microbial contami-
nation by proper design of the system, periodic sanitization and by taking appro-
priate measures to prevent microbial proliferation.
1.2.4 Dierent grades of water quality are required depending on the route
of administration of the pharmaceutical products. Other sources of guidance
about dierent grades of water can be found in pharmacopoeias and related
documents.
1.3 Applicable guides
1.3.1 In addition to the specic guidance provided in this document, the Further
reading section includes some relevant publications that can serve as additional
background material when planning, installing and using systems intended to
provide WPU.
2. General principles for pharmaceutical water systems
2.1 Pharmaceutical water production, storage and distribution systems should be
designed, installed, commissioned, qualied and maintained to ensure the reliable
production of water of an appropriate quality. It is necessary to validate the water
production process to ensure the water generated, stored and distributed is not
beyond the designed capacity and meets its specications.
2.2 The capacity of the system should be designed to meet the average and the
peak ow demand of the current operation. If necessary, depending on planned
future demands, the system should be designed to permit increases in the capac-
ity or designed to permit modication. All systems, regardless of their size and
capacity, should have appropriate recirculation and turnover to assure the system
is well controlled chemically and microbiologically.
2.3 The use of the systems following initial validation (installation qualication
(IQ), operational qualication (OQ) and performance qualication (PQ)) and aer
any planned and unplanned maintenance or modication work should be approved
by the quality assurance (QA) department using change control documentation.
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