Definition

A documented procedure that provides step-by-step instructions for performing pharmacovigilance activities consistently and in compliance with regulations.

Example

The SOP for expedited reporting defines who triages cases, criteria for expedited submission, steps for E2B transmission, and documentation requirements.

Regulatory source

EU GVP Module I, ICH E6

Common mistakes

Having SOPs that are overly complex, outdated, or not aligned with actual practice. SOPs must be practical and current.

Inspector question

Show me your SOP index. How do you ensure staff are trained and that SOPs reflect current practice?

Related terms