SQA MCQ 2 — Questions and Answers
Question 1: Under FDA 21 CFR Part 58, which individual is ultimately responsible for ensuring a GLP study is conducted in compliance with regulations?
- Study director
- Quality assurance unit
- Sponsor
- Testing facility management (Correct answer)
Correct answer: Testing facility management
Testing facility management bears ultimate responsibility for GLP compliance, including providing qualified personnel and resources.
Question 2: An SOP is found to have been used in its draft form for six months without final approval. Which CAPA element is MOST critical to address first?
- Root cause analysis of why the SOP was not approved (Correct answer)
- Retroactive validation of all work done under the draft SOP
- Immediate withdrawal of the draft SOP from use
- Notification to the FDA of the deviation
Correct answer: Root cause analysis of why the SOP was not approved
Root cause analysis must be completed first to understand the systemic failure before corrective and preventive actions can be properly designed.
Question 3: In GCP trials, what is the primary purpose of the Investigator's Brochure (IB)?
- To satisfy FDA submission requirements
- To provide investigators with clinical and nonclinical data about the investigational product (Correct answer)
- To document protocol deviations
- To serve as a training record for site staff
Correct answer: To provide investigators with clinical and nonclinical data about the investigational product
The IB compiles relevant clinical and nonclinical data to enable investigators to understand the rationale for and comply with the protocol.
Question 4: Which ICH guideline specifically addresses the stability testing of new drug substances and products?
- ICH Q1A(R2) (Correct answer)
- ICH Q2(R1)
- ICH Q7
- ICH E6(R2)
Correct answer: ICH Q1A(R2)
ICH Q1A(R2) provides guidance on stability testing of new drug substances and drug products, including storage conditions and testing intervals.
Question 5: A QA auditor discovers that chromatography data was reprocessed without documented justification. This is BEST classified as:
- A minor observation requiring monitoring
- A data integrity violation (Correct answer)
- A calibration failure
- A personnel training gap
Correct answer: A data integrity violation
Undocumented reprocessing of raw data constitutes a data integrity violation, which is a serious GxP compliance issue.
Question 6: In a pharmaceutical manufacturing environment, what does the term 'bracketing' refer to in the context of stability studies?
- Testing only the extremes of container sizes or strengths at all time points (Correct answer)
- Placing samples at the top and bottom of stability chambers
- Reducing the number of test parameters for cost savings
- Grouping similar products under one stability protocol
Correct answer: Testing only the extremes of container sizes or strengths at all time points
Bracketing tests only the extreme conditions (e.g., largest and smallest container sizes) at all time points, assuming intermediates are covered.
Question 7: According to FDA guidance on process validation, Stage 2 (Process Qualification) requires:
- Continued data collection and monitoring during routine production
- Design of the manufacturing process based on knowledge gained during development
- Confirmation that the process design can be reproduced at commercial scale (Correct answer)
- Completion of equipment installation qualification only
Correct answer: Confirmation that the process design can be reproduced at commercial scale
Stage 2 Process Qualification evaluates whether the process design can consistently produce acceptable product at commercial scale.
SQA MCQ 2
Under FDA 21 CFR Part 58, which individual is ultimately responsible for ensuring a GLP study is conducted in compliance with regulations?