Definition

The formal written reply to an inspection report, addressing each finding with root cause analysis, corrective actions, and preventive measures.

Example

Inspection response due within 30 days addresses each finding with: root cause analysis, immediate corrections taken, long-term preventive actions, implementation timeline, and effectiveness metrics.

Regulatory source

EU GVP Module III, Regional Requirements

Common mistakes

Providing vague responses without specific timelines, responsible persons, and measurable outcomes.

Inspector question

Who prepares your inspection responses? How do you ensure timely and adequate submission?

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