CVM Change Control & Deviation Management Flashcards

In change control, a 'validation impact assessment' should consider which of the following?

Answer: Whether the change could affect critical quality attributes or critical process parameters

A validation impact assessment must evaluate whether the proposed change could alter critical quality attributes (CQAs) or critical process parameters (CPPs) that affect product quality.

Which regulatory body's guidance document specifically addresses the investigation of OOS laboratory test results in pharmaceutical manufacturing?

Answer: FDA (Guidance for Industry: Investigating Out-of-Specification Test Results)

The FDA issued 'Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production' to provide a framework for OOS investigations.

What is the purpose of 'trend analysis' in deviation management?

Answer: To identify recurring deviations that may indicate systemic process problems requiring CAPA

Trend analysis of deviations identifies patterns or recurring issues that signal underlying systemic problems, enabling proactive CAPA before product quality is compromised.

When a change is made to a validated computerized system, what must typically be performed before returning the system to GMP use?

Answer: Regression testing and documented verification that the change did not adversely affect validated functions

Changes to validated computerized systems require regression testing to confirm that the modification did not unintentionally affect other validated functions before GMP use resumes.

Which concept describes the maximum acceptable residue level allowed to remain on equipment after cleaning validation?

Answer: Maximum Allowable Carryover (MACO)

Maximum Allowable Carryover (MACO) is the scientifically calculated limit for residue of a previous product that is acceptable on shared equipment before manufacturing the next product.

A 'change control log' in a pharmaceutical or medical device facility primarily serves to:

Answer: Provide a complete audit trail of all changes made to validated systems, processes, and documents

A change control log provides a comprehensive audit trail showing all proposed, approved, and implemented changes, which is essential for regulatory inspections and maintaining the validated state.