GMP Risk Analyses - nothing works without them

GMP risk analyses are a must. Every technically relevant system today is based on risk analyses. They serve primarily as a foundation for the individual qualification phases – whether for newly constructed systems or existing old installations. They help define the scope and depth of qualification. Thus, risk analyses should also be used and updated in the case of system changes, so that deviations can be assessed and their impacts reliably estimated.

GMP risk analyses are time-consuming. For each technical system, possible errors and their causes are initially compiled. Inspection measures and considerations for risk minimization follow, taking into account which each individual risk for each specific cause of error is ultimately evaluated.

GMP risk analyses require a lot of experience. There is no truly fixed procedure for conducting risk analyses; many companies follow the FMEA method. However, increasingly more companies are also seeking alternatives to avoid the discussion of numbers.

Precisely for this reason, gempex, together with the GMP publisher of Maas & Peither, has developed standard templates for GMP risk analyses. Thoughtful SOPs and suitable forms simplify the process, and systematically compiled collections of errors and their causes save valuable time – all supported by the experience of experts in this field.

Through regularly published supplementary issues, the collection of standard templates is continuously expanded in various areas.