Schedule M (revised 2024), validation, cleanrooms, water systems, WHO GMP
2%
of the paper
≈ 2 marks
#10
by weightage
of 13 topics
160
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
Air quality grades and monitoring thresholdsBiotech manufacturingClean room classification standardsCleanrooms & environmental monitoringDocumentation and operational proceduresEnvironmental control in transfer operationsEnvironmental monitoring and contamination controlEquipment cleaningEquipment maintenance and accuracyFacility controlsFacility design and contamination controlGMP documentationGMP frameworkIn-process quality controlPharmaceutical facility infrastructurePharmaceutical manufacturing standardsPharmaceutical water systemsPlant layoutPlant locationPremises & plantProcess control and regulatory complianceProcess validationProcess validation and quality assuranceQuality ControlQuality improvementSafety & hazardsSchedule M (incl. revised 2024)Self-inspectionSterility assurance process validationSupplier qualificationTraining frequency and documentationValidation & qualificationWHO GMPWHO herbal GMP
Sample questions, with the reasoning
Every question in the bank is explained like this — including why each wrong option is wrong.
A 'Critical Process Parameter' (CPP) in pharmaceutical manufacturing is a process parameter whose:
A)Setting must be identical across all batches regardless of equipment scale
B)Value determines only the manufacturing cost, not product quality
C)Variability has a significant impact on a Critical Quality Attribute (CQA) and therefore must be monitored and controlled✓
D)Value is fixed and cannot be changed during the process without prior CDSCO approval
Why C is correct
Per ICH Q8, a CPP is a process parameter whose variability has an impact on a CQA and therefore should be monitored or controlled to ensure the process produces the desired quality. Linking CPPs to CQAs through risk assessment is fundamental to the Quality by Design (QbD) approach.
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A "Travel Chart" is a record of:
A)Amount of travel by the material in a process✓
B)Amount of travel of labourers in a process
C)Amount of travel of machines in a process
D)Area of a pharmaceutical plant
Why A is correct
In plant-layout studies, a travel chart records the distances/frequency of MATERIAL movement between workstations, used to minimise material handling. Official TNPSC final key: A.
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A batch of a starting material fails to meet its IP specification on incoming testing. Which GMP action is mandatory?
A)Reroute to a non-critical manufacturing step where the specification is less stringent
B)Use the material with a risk assessment, provided the deviation is minor
C)Quarantine, label as REJECTED, segregate from approved materials, and arrange for disposal or return to supplier under documented procedures✓
D)Re-test the same sample three times; if two of three tests pass, release the material
Why C is correct
Any starting material that fails to meet its specification on incoming testing must immediately be quarantined, clearly labelled as REJECTED, and physically segregated from approved materials. Disposal or return to the supplier must follow documented procedures. No rerouting or re-testing to release is permitted without an authorised investigation.
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Practise S06 with real marking
160 questions · −1/3 negative marking · explanations after every answer. No sign-up needed to try.