Weightage is measured from previous Drug Inspector papers, not estimated. Question counts are read from the live bank when this page is built.
Subtopics in this bank
Clinical trialsData integrity and record-keeping in GLPDisinfectant evaluationEquipment maintenance and calibration requirementsGLP archival requirements and data retentionGLP non-compliance and regulatory actionMethod validation in GLP bioanalytical studiesOECD GLP principlesPharmacokineticsPharmacovigilance systemsProtocol deviation documentation and assessmentQA roles and responsibilities in GLPRecords retentionStability testingStudy design in GLP toxicology
Sample questions, with the reasoning
Every question in the bank is explained like this — including why each wrong option is wrong.
A Quality Assurance Unit (QAU) in a GLP-compliant facility has which primary responsibility?
A)Ensuring compliance with GLP principles through monitoring and audits✓
B)Approving experimental designs without review
C)Managing only equipment maintenance schedules
D)Conducting all analytical tests on samples
Why A is correct
GLP designates the QAU as independent oversight body responsible for routine monitoring, audits, and verification of facility compliance with GLP principles.
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A reference substance used in a GLP study must meet which criterion?
A)Re-testing by the facility each week to confirm stability
B)Certificate of Analysis with documented traceability to a recognized standard✓
C)Supplier's verbal assurance of quality is sufficient
D)Only identity confirmation; purity not required
Why B is correct
GLP requires reference substances to be of known identity, purity, and stability, with a documented chain of custody linking them to recognized standards (e.g., pharmacopeial standards).
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Acacia (gum arabic), used as an emulsifying and binding agent, is an example of which type of natural gum?
A)Exudate gum — a pathological product secreted from plant wounds✓
B)Seed gum — extracted from endosperm of seeds
C)Marine gum — extracted from seaweed
D)Biosynthetic gum — produced by microbial fermentation
Why A is correct
Acacia (gum arabic, from Acacia senegal) is an exudate gum — a pathological secretion produced by plants in response to injury or wounding. It is a complex polysaccharide containing arabinose, galactose, rhamnose, and glucuronic acid, with associated protein.
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Practise S07 with real marking
46 questions · −1/3 negative marking · explanations after every answer. No sign-up needed to try.