By Piritta Maunu, Regulatory Expert, Vaisala, Inc.
Assistance by Jim Tennermann and John Martin
Quality Risk Management (QRM) is an essential part of any pharmaceutical quality system. This article provides practical tools for creating a risk assessment procedure related to Good Distribution Practice (GDP) guidelines.
Risk assessment and control procedures are created to guarantee patient safety. There are two major principles to understand:
- When evaluating the potential risk of a certain parameter, the evaluation should be based on scientific knowledge
- The greater the potential risk, the more effort, evaluation and documentation is needed to assess this risk
Nine recommended steps for developing a GDP risk assessment and control procedure: