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Welcome to Module 3: Design Qualification,
or DQ.

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Our fictional vessel V-201 prepares an
aqueous oral solution before filling.

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It is not an aseptic process.

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The diagram connects intended purpose to a
proposed design

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and then to a reasoned decision.

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We ask whether the design can support the
intended use.

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A purchase order or attractive equipment

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drawing cannot answer that question by
itself.

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DQ evaluates the proposed design.

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Installation qualification examines what
was installed.

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Operational qualification challenges
operation,

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and performance qualification addresses

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performance for the intended use under
defined conditions.

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These questions are connected but not
interchangeable.

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A successful design review does

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not demonstrate that the installed vessel
mixes a real batch uniformly.

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Later modules examine those later stages.

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Keep the evidence and the decision
appropriate to the stage.

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Look at three design concerns: the product
contact path,

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the measurement chain and access for
cleaning.

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A vessel can have a suitable steel body
yet an unsuitable gasket.

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A temperature display can work

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while representing the wrong sensor
location.

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A shiny exterior can conceal a trapped
pocket.

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For each concern, ask which design feature
addresses the need,

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what evidence supports that claim and what
must later be verified.

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In this course, every equipment
identifier, specification

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and evidence reference is a teaching
invention.

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No site equipment has been qualified.

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At the end of a DQ review, state the
design scope,

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the evidence examined and the open
conditions.

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Do not write ready for routine production

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when only design evidence has been
assessed.

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Your first activity is to distinguish a
design

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conclusion from an installation finding
and a performance claim.