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BSc (Ord) Manufacture of Pharmaceutical ProductsWQ-1.Examine the graphicalrepresentation on the nextpage for “A ValidationApproach for a ComplexProject, Consisting of ManySystems and Components”.a.In terms of “Qualification Rationale”,describe the process of a system-impact-assessment and component-level-impact assessment.b.In your own words define the term installation qualification (IQ).c.In your own words define the term operational qualification (OQ).d.In your own words define the term performance qualification (IQ).Written QuestionsVOMP3001GetReSkilled/TUD2021Page 1
BSc (Ord) Manufacture of Pharmaceutical ProductsA Validation Approach for aComplex Project, Consisting of Many Systems and ComponentsHigh LevelStrategic PlanSystem LevelDetailProcess Validation DocumentationE.g. SOPs, Training Records, Cleaning Validation, AnalyticalProcedures, Validation Batches, etc.SystemQualificationProtocolSystem ‘X’ QualificationRationaleValidation Master PlanIQOQPQPQPQ RationaleOQIQSystemQualificationProtocolSystem 2 QualificationRationaleSystem 1 QualificationRationaleOQIQSystemQualificationProtocol

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Term
Fall
Professor
NoProfessor
Tags
Verification and validation, own words, Manufacture of Pharmaceutical Products

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