CVM CVM Change Control & Deviation Management 1 — Questions and Answers
Question 1: What is the primary purpose of a change control system in a validated environment?
- To document all employee performance reviews
- To ensure changes are assessed, approved, and implemented without adversely affecting product quality or validation status (Correct answer)
- To track equipment purchase orders
- To manage supplier contracts
Correct 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.
Question 2: Which document formally captures the details of an unexpected event that deviates from an approved procedure or specification?
- Change Request Form
- Deviation Report (Correct answer)
- Calibration Certificate
- Standard Operating Procedure
Correct answer: Deviation Report
A Deviation Report formally documents the circumstances, impact, and corrective actions for any unplanned departure from established procedures or specifications.
Question 3: In change control, what distinguishes a 'minor' change from a 'major' change?
- Minor changes are made by junior staff; major changes by senior staff
- Minor changes have no impact on validated state or product quality; major changes could affect them (Correct answer)
- Minor changes require no documentation; major changes require full revalidation
- Minor changes are cosmetic; major changes involve purchasing new equipment
Correct 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.
Question 4: A Corrective and Preventive Action (CAPA) system is used to:
- Schedule routine maintenance of equipment
- Address root causes of deviations and prevent recurrence (Correct answer)
- Approve annual budgets for validation projects
- Assign shift responsibilities to operators
Correct 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.
Question 5: Which regulatory expectation requires manufacturers to evaluate changes to validated processes before implementation?
- 21 CFR Part 11
- 21 CFR Part 211.68
- 21 CFR Part 211.100
- ICH Q10 Pharmaceutical Quality System (Correct answer)
Correct 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.
Question 6: What is a 'retrospective deviation' in validation management?
- A deviation identified after a process has already occurred and product may have been released (Correct answer)
- A planned process change scheduled for the future
- A deviation reported before any impact has occurred
- An approved exception to a specification
Correct 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.
CVM CVM Change Control & Deviation Management 1
What is the primary purpose of a change control system in a validated environment?