Minimising risks
Within the world of GMP (GxP), risk analyses are a standard component. All GMP processes and linked processes are subjected to analyses of:
- The risk
- The seriousness of the risk
- The frequency of the risk
There are several risk analysis methods, including the FMEA (Failure Mode & Effects Analysis), which we conduct in a very structured way at Advipro. The necessary documentation and actions are also provided to reduce the risk to an acceptable level. A multidisciplinary team gathers input to approach all aspects of risk.
In the new regulations (e.g. Eudralex Vol. 4, Annex 1 implementation August 2023), conducting risk analyses and managing risks is discussed in detail. It is a regular point of review during inspections by regulatory bodies.
Risk analysis - Advipro @ your service
- Conducting risk analysis studies
- Implementing actions after risk analysis
- Writing risk analysis procedures and documentation
- Risk analysis methods training
