Example Test Cases
Showing 19 example test cases from the benchmark. The full benchmark contains additional test cases not shown here to preserve evaluation integrity.
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Category
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Showing 19 of 19 test cases
According to 21 CFR Part 11, electronic signatures must be:
Knowledge QA21cfr11easy
electronic_signaturescompliance
Under 21 CFR Part 11 Section 11.10, which of the following is required
for systems that maintain closed electronic records?
Knowledge QA21cfr11hard
closed_systemsvalidationcompliance
Under 21 CFR Part 11, which of the following is NOT a requirement
for electronic records?
Knowledge QA21cfr11medium
electronic_recordscompliance
Create Batch Manufacturing Record for Metformin Tablets
Task CompletionBatch Recordhard
batch_recordtablet_manufacturingwet_granulationdocumentation
Generate EM Trending Report from Scattered Data
Task CompletionEm Reporthard
environmental_monitoringtrendingdata_analysis
EM Excursion Investigation Report
Task CompletionEm Reportmedium
environmental_monitoringdeviationinvestigation
According to EU GMP Annex 1 (2022 revision), what is the maximum permitted
total particle count for Grade A zones at rest for particles >= 0.5 um per m3?
Knowledge QAEu Annex1easy
cleanroom_classificationgrade_aparticle_limits
According to EU GMP Annex 1 (2022 revision), when performing Aseptic
Process Simulation (media fills) for conventional aseptic filling, what
is the maximum acceptable number of contaminated units when filling
fewer than 5,000 units?
Knowledge QAEu Annex1hard
media_fillsaseptic_process_simulationcontamination
Under the revised EU GMP Annex 1, what is the recommended maximum time
limit for holding filtered bulk solution before filling in an aseptic process,
unless otherwise justified?
Knowledge QAEu Annex1medium
aseptic_processingholding_timeprocess_validation
According to EU GMP Annex 11, what is the fundamental requirement
for computerised systems used in GMP-regulated activities?
Knowledge QAEu Annex11easy
validationrisk_assessmentcomputerised_systems
According to EU GMP Annex 11, what specific requirements apply to
data storage and archiving for computerised systems?
Knowledge QAEu Annex11hard
data_storagearchivingdata_integrityretention
Under EU GMP Annex 11, what are the requirements for audit trails
in computerised systems?
Knowledge QAEu Annex11medium
audit_trailsdata_integritygmp_relevant_changes
According to 21 CFR 211.192, what is required when any unexplained
discrepancy or failure of a batch to meet specifications is found?
Knowledge QAGeneral Gmpeasy
deviationsinvestigationbatch_disposition
According to 21 CFR 211.186, what specific information must be
included in master production and control records?
Knowledge QAGeneral Gmphard
batch_recordsmaster_recordsdocumentation
Under EU GMP Part I Chapter 1, what is the purpose of a Corrective
Action and Preventive Action (CAPA) system?
Knowledge QAGeneral Gmpmedium
capaquality_systemroot_cause
According to ICH Q7, at what point in the manufacturing process
should GMP be applied to the production of an API?
Knowledge QAIch Q7easy
starting_materialsgmp_application_point
According to ICH Q7, which of the following best describes the
requirements for impurity profiles of APIs?
Knowledge QAIch Q7hard
impurity_managementimpurity_profilequality_control
Under ICH Q7, what is the requirement for process validation of
API manufacturing processes?
Knowledge QAIch Q7medium
process_validationdocumented_evidence
Write Equipment Cleaning SOP
Task CompletionSopmedium
sopcleaningbioreactor