SQA MCQ 5

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:

Accepted Answer

Classify the finding as a critical deficiency and place the laboratory on hold pending correction

Answer

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?

Accepted Answer

Drug product development and manufacturing throughout the product lifecycle

Answer

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?

Accepted Answer

Clause 7.6 — Evaluation of measurement uncertainty

Answer

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:

Accepted Answer

Records demonstrating the design was developed in accordance with the approved design plan

Answer

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:

Accepted Answer

An ineffective CAPA that fails to address root cause if the system or process design is at fault

Answer

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.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA MCQ 5