Mixed Deck — All SQA Topics Flashcards

What is a 'remote audit' or 'desk audit' in pharmaceutical quality assurance?

Answer: An audit conducted by reviewing documents, records, and evidence submitted electronically without physically visiting the site

A remote audit reviews quality records, procedures, and data submitted electronically, enabling some level of quality oversight without requiring an on-site visit.

In GLP auditing, what is the purpose of a retrospective data audit?

Answer: To review completed raw data and records to verify accuracy, completeness, and GLP compliance after the fact

Retrospective data audits review completed study records to assess data integrity and GLP compliance of the documented study conduct.

What is the purpose of 'worst-case' testing in equipment or process validation?

Answer: To demonstrate that the process or equipment performs acceptably even under the most challenging but still realistic conditions

Worst-case testing challenges the process or equipment at boundary conditions most likely to result in failure, providing confidence that routine operations will always succeed.

What is a 'process audit' in the context of GLP quality assurance?

Answer: An audit that evaluates a specific work process against defined criteria such as SOPs or regulations

A process audit examines how a specific work process (e.g., sample processing, data recording) is performed compared to written procedures.

What is a 'periodic review' of SOPs in a GMP quality system?

Answer: A scheduled review to ensure SOPs remain accurate, current, and reflective of actual practice

Periodic review ensures SOPs are reviewed at regular intervals (typically every 2-3 years) to verify they still reflect current practices, regulations, and equipment.

Which of the following best describes 'study initiation date' under GLP guidelines?

Answer: The date the Study Director signs the protocol

The study initiation date is defined as the date the Study Director signs the study protocol.

Which GLP principle directly underpins the SQA's emphasis on quality assurance as a profession rather than merely a compliance function?

Answer: The belief that independent, expert oversight of study conduct protects data integrity and ultimately public health

SQA's professional philosophy is grounded in the principle that expert, independent QA oversight is essential to scientific integrity and protection of public health.

What is the significance of the OECD Mutual Acceptance of Data (MAD) framework for US sponsors submitting studies internationally?

Answer: Studies conducted under GLP in one OECD member country are accepted by other member countries, eliminating the need to duplicate studies

OECD MAD allows GLP-compliant studies from one member country to be submitted to regulatory authorities in other member countries without requiring study repetition.

What is a CAPA in the context of SQA regulatory compliance?

Answer: Corrective and Preventive Action

CAPA stands for Corrective and Preventive Action, a systematic FDA-required process to eliminate causes of non-conformances.

What is 'Continued Process Verification' (Stage 3 of FDA's process validation lifecycle)?

Answer: Ongoing monitoring of process performance during commercial manufacturing to ensure the process remains in a validated state

Stage 3 requires ongoing collection and statistical analysis of process data during commercial production to detect undesired variability and confirm the validated state is maintained.

What is the purpose of a closing meeting at the end of a GxP audit?

Answer: To present the audit findings to management, discuss their significance, and confirm factual accuracy before the formal audit report is issued

The closing meeting presents all audit findings to site management, allows clarification of factual accuracy, and sets expectations for the formal audit report and response timelines.

What is a User Requirements Specification (URS) in computer system validation?

Answer: A document that defines what the system must do from the user's perspective, forming the basis for all subsequent validation activities

The URS defines the functional and regulatory requirements the system must meet, and all validation test cases are designed to verify the system satisfies these requirements.

What distinguishes a 'for cause' audit from a routine audit in a pharmaceutical setting?

Answer: A for-cause audit is triggered by a specific event or concern such as a complaint or failure; routine audits are scheduled at regular planned intervals

For-cause audits are reactive, triggered by specific incidents like product failures or regulatory concerns, while routine audits are proactive and scheduled.

Which startup activity ensures that the test system (e.g., animals, cells) meets the protocol specifications before study procedures begin?

Answer: Test system acclimation and characterization

Acclimation and characterization confirm the test system's health, identity, and suitability prior to experimental procedures.

the method of testing used to ensure sure the system can manage unforeseen circumstances.

Answer: Negative Testing

Negative testing, also known as error path testing or failure testing, is a type of testing that verifies the system's ability to gracefully handle invalid inputs, unexpected user actions, or unforeseen circumstances. Its purpose is to ensure the software remains stable and secure when faced with conditions outside of its normal operational parameters, preventing crashes or data corruption.

In GxP record management, what is a 'quality record' versus a 'controlled document'?

Answer: Quality records are completed forms documenting activities performed; controlled documents are instructions or procedures to be followed

Controlled documents (SOPs, protocols) prescribe what to do, while quality records (logbooks, batch records) are the completed evidence that activities were performed as required.

What is the MACO calculation used for in cleaning validation?

Answer: To determine the maximum amount of a previous product residue that can remain on equipment without adversely affecting the next product

MACO (Maximum Allowable Carryover) defines the scientifically justified limit for residual carryover from a previous product to the next product, based on toxicological or therapeutic criteria.

What does a sample report look like that comes out of a quality assurance test?

Answer: Results for the Quality Assurance Test along with other assessments in a candidate report

A comprehensive candidate report from a quality assurance test typically consolidates all relevant assessment results into one document. This includes the scores and performance details from the QA test itself, often alongside data from other pre-employment assessments (e.g., cognitive ability, personality). This integrated report provides a holistic view of the candidate's strengths and suitability for the role.

In SQA auditing, what does 'objective evidence' mean?

Answer: Verifiable information such as records, statements of fact, or observations that support audit findings, free from subjectivity

Objective evidence is factual information (records, test results, observable conditions) that can be verified and supports audit conclusions without relying on opinion or assumption.

Under the SQA auditing framework, what is the key distinction between an 'observation' and a 'nonconformance'?

Answer: An observation is a potential concern or improvement opportunity; a nonconformance is an actual regulatory or procedural violation

Observations flag risks or improvement opportunities without a clear regulatory violation, while nonconformances document actual departures from requirements.