Practical Considerations to Risk Assessments for Efficient Use in Pharmaceutical Development and Production

For QbD approaches a broad spectrum of various risk assessment tools is described in ICH Q9 and literature. All tools have specific strengths and therefore ideal problem settings they are applied to. However, in industrial practice large crossfunctional teams in varying composition of members are asked to conduct routinely risk assessments with high quality and in an efficient manner. It is close to impossible to keep these broad populations all equally trained and experienced in the use of multiple risk assessment tools. The talk will discuss selected tools we found viable for routine risk assessment throughout technical development up to commercial production.