SQA MCQ 3 — Questions and Answers
Question 1: Which ALCOA+ principle requires that electronic records cannot be altered without leaving a detectable audit trail?
- Attributable
- Legible
- Original (Correct answer)
- Accurate
Correct answer: Original
The 'Original' principle ensures that first-captured data is preserved and any changes are traceable, supporting data integrity.
Question 2: During a for-cause inspection, FDA investigators request all emails related to a batch failure. The QA manager should:
- Provide only emails from the QA department
- Consult legal counsel and provide requested records in accordance with applicable law (Correct answer)
- Decline until a formal request is submitted in writing
- Provide summary reports rather than original emails
Correct answer: Consult legal counsel and provide requested records in accordance with applicable law
Responding to FDA inspection requests requires legal guidance to ensure compliance while protecting legitimate privileges.
Question 3: Which type of equipment qualification confirms that installed equipment operates within specified limits when connected to its utilities?
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ) (Correct answer)
- Performance Qualification (PQ)
Correct answer: Operational Qualification (OQ)
Operational Qualification (OQ) verifies that equipment operates correctly within defined parameters under normal and edge conditions.
Question 4: A risk assessment using FMEA assigns a Risk Priority Number (RPN) by multiplying three factors. Which combination is correct?
- Severity × Occurrence × Detectability (Correct answer)
- Probability × Impact × Frequency
- Severity × Frequency × Control
- Likelihood × Consequence × Vulnerability
Correct answer: Severity × Occurrence × Detectability
FMEA RPN = Severity × Occurrence × Detectability, allowing teams to prioritize failure modes for corrective action.
Question 5: Under 21 CFR Part 11, which of the following is NOT a requirement for electronic signatures?
- The signature must be linked to the respective electronic record
- The signature must contain the full name of the signer
- The signature must be witnessed by a supervisor (Correct answer)
- The signature must include the date and time
Correct answer: The signature must be witnessed by a supervisor
21 CFR Part 11 does not require a supervisor witness for electronic signatures; it requires linkage, identity, date/time, and meaning.
Question 6: In the context of pharmaceutical QA, 'change control' is best described as:
- A process for managing software updates only
- A formal system to evaluate the effect of changes before implementation to prevent unintended consequences (Correct answer)
- A tool used exclusively during FDA inspections
- A retrospective review of past manufacturing deviations
Correct answer: A formal system to evaluate the effect of changes before implementation to prevent unintended consequences
Change control is a prospective system ensuring changes are assessed for impact on quality, safety, and efficacy before being implemented.
Question 7: Which WHO guideline framework is the international equivalent of FDA's GMP for pharmaceutical manufacturers?
- WHO Technical Report Series 986 (Correct answer)
- ICH Q10
- ISO 9001:2015
- PIC/S PE 009
Correct answer: WHO Technical Report Series 986
WHO TRS 986 Annex 2 contains WHO GMP guidelines widely adopted by regulatory authorities in countries without their own GMP framework.
SQA MCQ 3
Which ALCOA+ principle requires that electronic records cannot be altered without leaving a detectable audit trail?