SQA MCQ 4 — Questions and Answers
Question 1: A laboratory analyst discovers a chromatographic peak that was not present in the system suitability blank. The FIRST action should be:
- Report the finding to QA and document the observation before taking further action (Correct answer)
- Repeat the injection immediately to see if the peak persists
- Discard the result and begin a fresh analysis
- Adjust the baseline integration to exclude the peak
Correct answer: Report the finding to QA and document the observation before taking further action
GLP/GMP requires anomalies be documented contemporaneously; reporting to QA before taking action prevents unauthorized data manipulation.
Question 2: In a GMP audit, an auditor finds an 'out-of-specification' (OOS) result was invalidated based solely on the analyst's assumption of a 'calculation error,' with no documented laboratory investigation. This is:
- Acceptable if the analyst has 10+ years of experience
- An OOS invalidation that requires full phase II investigation before invalidation (Correct answer)
- Allowable under FDA's 'de minimis' exception
- Standard industry practice for obvious clerical errors
Correct answer: An OOS invalidation that requires full phase II investigation before invalidation
FDA's OOS guidance requires a full phase I and if needed phase II investigation with documented evidence before an OOS result can be invalidated.
Question 3: Which document type serves as the master template defining all critical parameters, equipment, and procedures for a specific product's manufacture?
- Batch production record
- Master manufacturing record (Correct answer)
- Product specification sheet
- Validation summary report
Correct answer: Master manufacturing record
The Master Manufacturing Record (MMR) or Master Batch Record is the authoritative document from which individual batch records are derived.
Question 4: Under ICH Q9 (Quality Risk Management), the risk management process includes all of the following EXCEPT:
- Risk identification
- Risk analysis
- Risk elimination (Correct answer)
- Risk communication
Correct answer: Risk elimination
ICH Q9 describes risk assessment, risk control (reduction/acceptance), and risk communication — not risk elimination, which is rarely achievable.
Question 5: What is the primary distinction between a 'deviation' and a 'non-conformance' in pharmaceutical QA?
- Deviations occur during manufacturing; non-conformances occur in the laboratory
- A deviation is a planned departure from procedure; a non-conformance is an unplanned failure to meet a requirement (Correct answer)
- Non-conformances require CAPA; deviations do not
- Deviations apply to APIs only; non-conformances apply to finished products
Correct answer: A deviation is a planned departure from procedure; a non-conformance is an unplanned failure to meet a requirement
A deviation is typically an unplanned departure from an approved procedure, while some frameworks distinguish non-conformances as failures to meet product/process specifications.
Question 6: In a GCP clinical trial, 'blinding' is maintained primarily to:
- Protect the identity of the investigational product's manufacturer
- Prevent bias in the evaluation of treatment outcomes (Correct answer)
- Comply with IRB documentation requirements
- Reduce the number of required study subjects
Correct answer: Prevent bias in the evaluation of treatment outcomes
Blinding prevents knowledge of treatment assignment from influencing subject behavior or investigator assessments, minimizing bias.
Question 7: A pharmaceutical company is implementing a new LIMS. According to GAMP 5, this software would be categorized as:
- Category 1 (Infrastructure software)
- Category 3 (Non-configured software)
- Category 4 (Configured software) (Correct answer)
- Category 5 (Custom software)
Correct answer: Category 4 (Configured software)
LIMS systems are typically Category 4 (configured software) — commercial off-the-shelf systems configured to meet specific user requirements.
SQA MCQ 4
A laboratory analyst discovers a chromatographic peak that was not present in the system suitability blank.
The FIRST action should be: