Topics covered
- GMP fundamentals
- QMS documentation hierarchy
- CAPA and deviations
- ICH Q8–Q10
- Data integrity
10 Quality Assurance (QA) MCQs with answers
- Q1
What does GMP stand for?
- AGood Manufacturing Practice
- BGeneral Material Procedure
- CGlobal Medicine Protocol
- DGuided Manual Process
Explanation: GMP = Good Manufacturing Practice, the system ensuring products are consistently produced and controlled to quality standards.
- Q2
Which document defines the quality policy and objectives of a company?
- ASOP
- BQuality Manual
- CBMR
- DDMF
Explanation: The Quality Manual is the top-level document describing the Quality Management System.
- Q3
CAPA stands for:
- ACorrective Action Preventive Action
- BContinuous Audit Process Approval
- CCompliance Assessment Performance Audit
- DCritical Analysis of Process Assurance
Explanation: CAPA = Corrective Action and Preventive Action — the systematic approach to investigate and prevent recurrence of issues.
- Q4
Which of the following is NOT a principle of GMP?
- AValidated processes
- BTrained personnel
- CDocumented procedures
- DMaximum production speed
Explanation: Speed is not a GMP principle — quality, consistency, and documentation are.
- Q5
A change control system is used to:
- AHide deviations
- BManage and document changes to validated systems
- CIncrease production output
- DReplace SOPs
Explanation: Change control ensures changes are evaluated, approved, documented, and implemented in a controlled manner.
- Q6
Which is the highest level of documentation in a QMS?
- ASOPs
- BQuality Manual
- CRecords
- DWork Instructions
Explanation: Quality Manual sits at the top, followed by procedures, work instructions and records.
- Q7
Out-of-Specification (OOS) results must be:
- AIgnored if minor
- BInvestigated as per SOP
- CReported only to QC
- DDiscarded silently
Explanation: All OOS results must be formally investigated per a written procedure (e.g., FDA OOS guidance).
- Q8
Annual Product Quality Review (APQR) is a requirement of:
- AICH Q7
- BICH Q10
- CICH Q1A
- DICH Q3D
Explanation: APQR/PQR is described under ICH Q10 (Pharmaceutical Quality System) and 21 CFR 211.180(e).
- Q9
Which of the following is a Quality Risk Management tool?
- AFMEA
- BHPLC
- CFTIR
- DTLC
Explanation: FMEA (Failure Mode and Effects Analysis) is a QRM tool described in ICH Q9.
- Q10
Deviation is defined as:
- AApproved change
- BDeparture from approved procedure
- CCalibration record
- DTest method
Explanation: A deviation is any departure from an approved instruction or established standard.
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