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

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?

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

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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.

SQA - Society of Quality Assurance Practice Test

SQA - Society of Quality Assurance Practice Test

SQA SQA Validation and Qualification 2