SQA MCQ 5 — Questions and Answers
Question 1: During a supplier qualification audit, you discover the contract laboratory has no documented training records for analysts performing GLP studies. The MOST appropriate immediate action is:
- Accept the laboratory conditionally and request records within 30 days
- Classify the finding as a critical deficiency and place the laboratory on hold pending correction (Correct answer)
- Recommend the laboratory for disqualification from all future contracts
- Document the observation and continue using the laboratory for non-GLP work
Correct answer: Classify the finding as a critical deficiency and place the laboratory on hold pending correction
Absence of training records for GLP analysts is a critical finding that poses direct risk to data integrity and must halt work until resolved.
Question 2: The 'pharmaceutical quality system' as defined by ICH Q10 encompasses which scope?
- Manufacturing operations only
- Drug product development and manufacturing throughout the product lifecycle (Correct answer)
- Regulatory submission preparation
- Post-market surveillance exclusively
Correct answer: Drug product development and manufacturing throughout the product lifecycle
ICH Q10 defines a holistic pharmaceutical quality system spanning development, technology transfer, manufacturing, and product discontinuation.
Question 3: When conducting a gap analysis for ISO 17025 accreditation, a laboratory identifies that its measurement uncertainty is not calculated for all quantitative test methods. This gap would affect which clause?
- Clause 5.4 — Review of requests, tenders and contracts
- Clause 7.6 — Evaluation of measurement uncertainty (Correct answer)
- Clause 6.4 — Equipment
- Clause 8.2 — Internal audit
Correct answer: Clause 7.6 — Evaluation of measurement uncertainty
ISO/IEC 17025:2017 Clause 7.6 specifically requires laboratories to identify and evaluate measurement uncertainty for all quantitative methods.
Question 4: Under FDA 21 CFR Part 820 (QSR for medical devices), the Design History File (DHF) must contain:
- All financial records related to device development
- Records demonstrating the design was developed in accordance with the approved design plan (Correct answer)
- Marketing approval documentation only
- Post-market surveillance data exclusively
Correct answer: Records demonstrating the design was developed in accordance with the approved design plan
The DHF must contain records demonstrating that the design was developed in conformance with the design and development plan per 21 CFR 820.30.
Question 5: A QA manager is reviewing a CAPA for a recurring contamination event. The corrective action proposed is 'retrain all personnel.' This is most likely:
- A well-targeted corrective action addressing root cause
- An ineffective CAPA that fails to address root cause if the system or process design is at fault (Correct answer)
- Sufficient to close the CAPA if training records are updated
- Appropriate as a preventive action for future personnel
Correct answer: An ineffective CAPA that fails to address root cause if the system or process design is at fault
Retraining as a CAPA is frequently ineffective when the real root cause is a process, equipment, or system design failure rather than human knowledge gaps.
Question 6: In a GMP facility, the term 'concurrent validation' means:
- Validation performed after routine production has begun, using data from production batches (Correct answer)
- Validation of multiple products simultaneously
- Validation completed before any commercial product is released
- Validation conducted in parallel with equipment qualification
Correct answer: Validation performed after routine production has begun, using data from production batches
Concurrent validation involves releasing product while validation is ongoing, using data from commercial-scale batches to demonstrate process consistency.
Question 7: Which of the following best describes the role of the Quality Unit as required by 21 CFR Part 211?
- To assist production in meeting daily output targets
- To have the authority and responsibility to approve or reject all drug product components, containers, and records (Correct answer)
- To report directly to manufacturing operations management
- To perform all laboratory testing required for batch release
Correct answer: To have the authority and responsibility to approve or reject all drug product components, containers, and records
21 CFR 211.22 requires the quality unit to have authority to approve or reject all components, drug product containers, closures, labeling, and records.
SQA MCQ 5
During a supplier qualification audit, you discover the contract laboratory has no documented training records for analysts performing GLP studies.
The MOST appropriate immediate action is: