Lesson 3.1
What DQ decides — and what it does not
Separate a design decision from installation checks and process performance.
Open lesson 3.1 →Module 03 · Self-paced learning
Design Qualification (DQ)
Turn a proposed pharmaceutical design into a defensible, evidence-linked decision.
10 narrated lessons40 diagrams10 worked examples2 interactive explorers
Start Lesson 3.1 →Continue the V-201 case
Review a fictional oral-liquid mixing vessel. No aseptic process, site-specific acceptance criteria or actual qualification records are represented.
Prerequisite: Module 2 — VMP, URS and Risk Assessment.
Learning time and format
21.7 minutes of narration. Allow approximately 4–5 hours including 200 minutes of suggested practice, reading and assessment. These are unmeasured planning estimates, not accredited contact time.
Core explanations and worked reasoning are narrated. Reference tables restate the examples; activities and model answers are reading exercises.
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Lessons
Lesson 3.2
Build a controlled design-review baseline
Identify the requirements, specifications and revisions that define the review.
Open lesson 3.2 →Lesson 3.3
Trace a requirement to a design decision
Write an evidence-linked DQ row that keeps later testing visible.
Open lesson 3.3 →Lesson 3.4
Review contact materials and cleanability
Connect product-contact design to evidence without assuming a universal material specification.
Open lesson 3.4 →Lesson 3.5
Review instruments, controls and failure responses
Evaluate the design of control protection without assuming two displays mean independence.
Open lesson 3.5 →Lesson 3.6
Review utility and installation interfaces
Find design assumptions at boundaries before they become installation surprises.
Open lesson 3.6 →Lesson 3.7
Use risk to focus the design review
Prioritize design scrutiny using failure mechanisms and evidence rather than a score alone.
Open lesson 3.7 →Lesson 3.8
Evaluate supplier evidence without transferring accountability
Assess vendor documentation for relevance, quality and configuration applicability.
Open lesson 3.8 →Lesson 3.9
Handle design findings and changes
Keep unresolved design gaps separate from authorized progression decisions.
Open lesson 3.9 →Lesson 3.10
Capstone: defend the DQ handover
Make an evidence-based design decision and carry open verification needs into IQ.
Open lesson 3.10 →Workbook and templates · 20-question assessment · Sources and privacy · Review package