CVM Change Control & Deviation Management Flashcards

What is the primary purpose of a change control system in a validated environment?

Answer: To ensure changes are assessed, approved, and implemented without adversely affecting product quality or validation status

A change control system ensures that any modification to validated processes, systems, or equipment is evaluated and approved before implementation to protect product quality.

Which document formally captures the details of an unexpected event that deviates from an approved procedure or specification?

Answer: Deviation Report

A Deviation Report formally documents the circumstances, impact, and corrective actions for any unplanned departure from established procedures or specifications.

In change control, what distinguishes a 'minor' change from a 'major' change?

Answer: Minor changes have no impact on validated state or product quality; major changes could affect them

Change classification is based on the potential impact on validated status, product quality, and regulatory compliance, with major changes typically requiring revalidation activities.

A Corrective and Preventive Action (CAPA) system is used to:

Answer: Address root causes of deviations and prevent recurrence

CAPA systems are designed to identify root causes of problems, implement corrections, and establish preventive measures to stop recurrence.

Which regulatory expectation requires manufacturers to evaluate changes to validated processes before implementation?

Answer: ICH Q10 Pharmaceutical Quality System

ICH Q10 establishes the expectation that a change management system evaluates planned changes to ensure the validated state and product quality are maintained.

What is a 'retrospective deviation' in validation management?

Answer: A deviation identified after a process has already occurred and product may have been released

A retrospective deviation is identified after the fact, requiring impact assessment on released product and potential recall evaluation.