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 
Quality Risk Management

Leave the risk analysis of your pharmaceutical company to experts.