CVM Change Control & Deviation Management Flashcards

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

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

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.

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

Answer: Impact assessment on validation and regulatory filings

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

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

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

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

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

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

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

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

Answer: Fishbone (Ishikawa) diagram

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.

After implementing a CAPA, what is the critical final step to close the CAPA record?

Answer: Verifying the effectiveness of the corrective/preventive action to confirm recurrence was prevented

Effectiveness verification confirms that the implemented CAPA actually resolved the root cause and prevented recurrence, which is required before the CAPA can be formally closed.