Definition

The ongoing effort to enhance pharmacovigilance processes, systems, and outcomes through systematic evaluation and implementation of improvements.

Example

Continuous improvement activities include: trend analysis of QC metrics, process efficiency reviews, technology upgrades, and implementation of regulatory guidance updates.

Regulatory source

ICH Q10, Quality Management

Common mistakes

Treating improvement as a one-time project rather than an ongoing organizational commitment.

Inspector question

Give examples of recent process improvements in your PV operations. How do you identify improvement opportunities?

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