S05

Vaccines, Sera & Biotech Products

Vaccine platforms, cold chain, CDL Kasauli, biosimilars, rDNA guidelines

4.5%
of the paper
≈ 5 marks
#8
by weightage
of 13 topics
137
questions
with explanations
0
cite a provision
Act, Rule or Schedule

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

Antisera productionBooster schedulesCombined vaccinesContinuous cultureDiagnostic detection target (hormone immunoassay)Egg protein in vaccine formulations and allergy contraindicationsEpidemiological aspects of vaccinationFermentationImmune mechanisms of inactivated vaccinesImmunity typesImmunization principlesImmunization vaccinesImmunological testsIn-vitro diagnostic kits — analyte detectedManufacturing and lot control in vaccine productionMonoclonalsPlant growth regulatorsPlant tissue culturePopulation immunityRecombinant DNA productsRoute of administration errors and corrective actionSera & antitoxinsTemperature-controlled storage for live attenuated vaccinesToxinsToxoid vaccines and mechanism of actionToxoidsTypes and classifications of vaccinesTypes of immunityVaccine cold chain requirementsVaccine composition and serotype coverageVaccine contraindicationsVaccine dosing schedules and immunization protocolsVaccine excipientsVaccine formulationVaccine immunologyVaccine manufactureVaccine performanceVaccine quality control and potency testingVaccine routesVaccine storageVaccine typesVaccine types & platformsVisual inspection and vaccine integrity

Sample questions, with the reasoning

Every question in the bank is explained like this — including why each wrong option is wrong.

______ cultures are initiated from an explant of seedling or other plant tissue sources.

  • A)Shoot tip
  • B)Sub
  • C)Callus
  • D)Suspension

Why C is correct

Callus cultures are initiated by placing an explant (from seedling or other tissue) on solid medium, where dedifferentiated callus proliferates; suspensions are then derived from callus. Official TNPSC final key: C.

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A batch of polio vaccine (IPV) manufactured in India requires batch release certification. Which organization is legally authorized to issue this?

  • A)Manufacturing company's quality assurance (QA) department
  • B)Central Bureau of Pharmaceutical Statistics (CBPS)
  • C)State Drug Regulatory Authority (SDRA)
  • D)Central Drugs Laboratory (CDL), Kasauli

Why D is correct

Central Drugs Laboratory (CDL), Kasauli, established under the D&C Act 1940, is the official agency authorized to test and certify vaccine batches. CDL issues 'Certification of Release' before vaccines are distributed, ensuring compliance with national and international standards.

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A batch of vaccine is stored in a freezer at −20°C for 18 months. The vial is removed for use during a disease outbreak. Is this vaccine safe to administer?

  • A)Yes, because freezing does not damage vaccine antigens
  • B)Yes, if it was stored in the dark and no visible changes are observed
  • C)No, because the vaccine is beyond its normal shelf life and must be discarded
  • D)No, because freezing damages vaccine potency for most vaccine types; prior stability data for this vaccine at −20°C must be reviewed

Why D is correct

Most vaccines are NOT stable at freezing temperatures (−20°C). Freezing causes protein aggregation, denaturation, and loss of potency. Vaccines approved for storage at −20°C are rare and specific. Stability data for the particular vaccine must be consulted. Without approval for freezing, this product should not be used.

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Practise S05 with real marking

137 questions · −1/3 negative marking · explanations after every answer. No sign-up needed to try.

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