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
AI and automation in GMP complianceAPI regulatory standards and inspectionsAct: definitionsAct: historyAct: offences & penaltiesAct: scopeAnti-counterfeiting measures and track-and-traceApplication approval procedures and timelinesConsent withdrawal and data governanceContent uniformity acceptance criteriaControlled substance scheduling and restrictionsCosmetics Rules 2020Cosmetics Rules 2020 / FormsD&C Act Schedules and quality standardsD&M Remedies Act 1954DCGI authority and responsibilitiesDPCO 2013 / NPPADTAB/DCCDomestic API capacity buildingDrug labeling standards and requirementsDrug schedulesEarly indicators of chemical incompatibilityElegant formulation design principlesFlow agents in tablet formulationFormsIndian Pharmacopoeia Commission authorityInternational regulatory harmonizationLaboratory standardsLicense issuance and facility approvalLicensing authoritiesLicensing authorities / regulatory bodiesLicensing authority and jurisdictionMarket withdrawal and recall authorityMedical Devices Rules 2017Modern validation and process controlNDA requirements and dossier structureNew Drugs & Clinical Trials Rules 2019Patents Act 1970Pharmaceutical industry trendsPharmacopoeia standardsPharmacovigilance regulatory expectationsPharmacy Act 1948Pharmacy education regulationPost-marketing surveillance and DCGI notificationQuality by Design methodologyRegulation of traditional and herbal medicinesRegulatory agenciesRegulatory bodiesRegulatory inspection and compliance strategiesRegulatory pathwaysRules 1945Rules 1945: FormsRules 1945: Forms · licensing authoritiesRules 1945: Schedules A-YRules 1945: Schedules A–YRules 1945: licensingRules 1945: licensing authoritiesSchedule Y and investigational drug protocolsSchedules A–YViolation of labeling standards and criminal provisionsWater system microbiological controlWeight-based dosing formulas
Sample questions, with the reasoning
Every question in the bank is explained like this — including why each wrong option is wrong.
'Design output', as defined in Schedule M-III, is significant because the finished design output:
A)Constitutes the manufacturer's quality policy
B)Is the basis for the device master record✓
C)Is the physical and performance requirement used as a basis for device design
D)Replaces the need for design review
Why B is correct
The definition states that the finished design output is the basis for the device master record, comprising the device, its packaging, labeling and that record.
Source: Drugs and Cosmetics Rules, 1945, Schedule M-III, para 3
Source cited
'Management with executive responsibility' is defined in Schedule M-III by reference to:
A)The person conducting the quality audit
B)Any employee involved in production operations
C)Senior employees having authority to establish or change the quality policy and quality system✓
D)The authority notifying devices for the purposes of this Schedule
Why C is correct
The term is defined by seniority plus authority to establish or change the manufacturer's quality policy and quality system.
Source: Drugs and Cosmetics Rules, 1945, Schedule M-III, para 3
Source cited
A batch has to be reprocessed. Which of the following consequences follows?
A)The batch may be released without recording the reprocessing
B)The batch is exempt from further evaluation once reprocessing succeeds
C)The reprocessed batch shall be subjected to stability evaluation✓
D)Investigation into the cause is optional if corrective measures are taken
Why C is correct
Reprocessing must be authorised and recorded, its causes investigated, corrective measures taken to prevent recurrence, and the reprocessed batch put through stability evaluation.
Source: Drugs and Cosmetics Rules, 1945, Rule 24
Source cited
Practise S10 with real marking
1453 questions · −1/3 negative marking · explanations after every answer. No sign-up needed to try.