SQA SQA Validation and Qualification 2

Question 1

What is computer system validation (CSV) in the pharmaceutical industry?

Accepted Answer

The documented process of demonstrating that a computer system consistently performs its intended functions reliably in compliance with 21 CFR Part 11

Answer

Installing antivirus and security software on all laboratory computers

Answer

Backing up electronic GxP data to a secure offsite server

Answer

Training users on a new software application before it goes live

Question 2

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

Accepted Answer

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

Answer

A user manual describing how to operate the validated software application

Answer

A vendor-provided description of all the software's features and capabilities

Answer

A formal report summarizing user acceptance testing results and conclusions

Question 3

In cleaning validation, what does a swab recovery study determine?

Accepted Answer

The efficiency with which the swabbing technique recovers residues from a surface, expressed as a recovery percentage

Answer

The type of cleaning agent needed to remove a particular product residue

Answer

The maximum allowable residue limit for a given product contact surface

Answer

The minimum time required for a cleaning cycle to be effective

Question 4

What is the MACO calculation used for in cleaning validation?

Accepted Answer

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

Answer

To calculate the minimum cleaning agent concentration for each cleaning cycle

Answer

To determine the maximum batch size allowable for a new product on the equipment

Answer

To set the minimum cleaning time required for each piece of equipment

Question 5

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

Accepted Answer

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

Answer

To determine the absolute maximum stress equipment can withstand before it fails

Answer

To identify conditions that will always cause a process to fail and set hard limits

Answer

To test equipment at conditions well outside of its normal intended operating range

Question 6

What triggers a revalidation requirement in pharmaceutical manufacturing?

Accepted Answer

Significant changes to equipment, materials, process parameters, or facilities that could impact product quality

Answer

Routine annual review of all existing validation documentation and reports

Answer

Employee turnover in key positions within the manufacturing department

Answer

Addition of a new unrelated product to a completely separate manufacturing line