SQA MCQ 4

Question 1

A laboratory analyst discovers a chromatographic peak that was not present in the system suitability blank. The FIRST action should be:

Accepted Answer

Report the finding to QA and document the observation before taking further action

Answer

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:

Accepted Answer

An OOS invalidation that requires full phase II investigation before invalidation

Answer

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?

Accepted Answer

Master manufacturing record

Answer

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:

Accepted Answer

Risk elimination

Answer

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?

Accepted Answer

A deviation is a planned departure from procedure; a non-conformance is an unplanned failure to meet a requirement

Answer

A deviation is typically an unplanned departure from an approved procedure, while some frameworks distinguish non-conformances as failures to meet product/process specifications.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA MCQ 4