SQA SQA Validation and Qualification 2 — Questions and Answers
Question 1: What is computer system validation (CSV) in the pharmaceutical industry?
- The documented process of demonstrating that a computer system consistently performs its intended functions reliably in compliance with 21 CFR Part 11 (Correct answer)
- Installing antivirus and security software on all laboratory computers
- Backing up electronic GxP data to a secure offsite server
- Training users on a new software application before it goes live
Correct answer: The documented process of demonstrating that a computer system consistently performs its intended functions reliably in compliance with 21 CFR Part 11
CSV is the documented evidence that a computer system does what it is intended to do reliably, meeting applicable regulations including 21 CFR Part 11.
Question 2: What is a User Requirements Specification (URS) in computer system validation?
- A document that defines what the system must do from the user's perspective, forming the basis for all subsequent validation activities (Correct answer)
- A user manual describing how to operate the validated software application
- A vendor-provided description of all the software's features and capabilities
- A formal report summarizing user acceptance testing results and conclusions
Correct 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.
Question 3: In cleaning validation, what does a swab recovery study determine?
- The efficiency with which the swabbing technique recovers residues from a surface, expressed as a recovery percentage (Correct answer)
- The type of cleaning agent needed to remove a particular product residue
- The maximum allowable residue limit for a given product contact surface
- The minimum time required for a cleaning cycle to be effective
Correct answer: The efficiency with which the swabbing technique recovers residues from a surface, expressed as a recovery percentage
A swab recovery study determines how efficiently the sampling technique recovers spiked residues from representative surface materials, allowing correction of actual residue measurements.
Question 4: What is the MACO calculation used for in cleaning validation?
- To determine the maximum amount of a previous product residue that can remain on equipment without adversely affecting the next product (Correct answer)
- To calculate the minimum cleaning agent concentration for each cleaning cycle
- To determine the maximum batch size allowable for a new product on the equipment
- To set the minimum cleaning time required for each piece of equipment
Correct 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.
Question 5: What is the purpose of 'worst-case' testing in equipment or process validation?
- To demonstrate that the process or equipment performs acceptably even under the most challenging but still realistic conditions (Correct answer)
- To determine the absolute maximum stress equipment can withstand before it fails
- To identify conditions that will always cause a process to fail and set hard limits
- To test equipment at conditions well outside of its normal intended operating range
Correct 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.
Question 6: What triggers a revalidation requirement in pharmaceutical manufacturing?
- Significant changes to equipment, materials, process parameters, or facilities that could impact product quality (Correct answer)
- Routine annual review of all existing validation documentation and reports
- Employee turnover in key positions within the manufacturing department
- Addition of a new unrelated product to a completely separate manufacturing line
Correct answer: Significant changes to equipment, materials, process parameters, or facilities that could impact product quality
Revalidation is required when changes are made to a validated system that could affect product quality, as identified through the change control process.
SQA SQA Validation and Qualification 2
What is computer system validation (CSV) in the pharmaceutical industry?