SQA Validation and Qualification Flashcards

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

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.

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.

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

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.

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 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 triggers a revalidation requirement in pharmaceutical manufacturing?

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.