CVM CVM Change Control & Deviation Management 2

Question 1

What is the recommended first step when a validated process experiences an out-of-specification (OOS) result?

Accepted Answer

Initiate a laboratory investigation to determine if it is a true OOS or a laboratory error

Answer

Per FDA guidance, the first step is to assess whether the OOS result stems from a laboratory error before concluding it is a true process failure.

Question 2

Which element is essential in a change control procedure to protect validated status?

Accepted Answer

Impact assessment on validation and regulatory filings

Answer

An impact assessment evaluates whether the proposed change affects the validated state, regulatory submissions, or product quality before approval.

Question 3

What does 'revalidation' mean in the context of change control?

Accepted Answer

Re-executing validation protocols after a significant change to confirm validated state is maintained

Answer

Revalidation involves re-executing relevant validation protocols after a major change to demonstrate that the process still performs within specified parameters.

Question 4

A 'planned deviation' (also called a temporary deviation or exception) is best described as:

Accepted Answer

A pre-approved, time-limited departure from a standard procedure for a specific batch or event

Answer

A planned deviation is approved in advance for a specific situation where following the standard procedure is not possible, with defined scope and timeframe.

Question 5

Which tool is most commonly used to perform root cause analysis for deviations?

Accepted Answer

Fishbone (Ishikawa) diagram

Answer

The Fishbone (Ishikawa) diagram is a structured root cause analysis tool that categorizes potential causes (man, machine, method, material, environment, measurement) contributing to a deviation.

CVM - Certified Validation Manager Practice Test

CVM - Certified Validation Manager Practice Test

CVM CVM Change Control & Deviation Management 2