News

In December 2020, you could already read about the ICH announcement to revise the ICH Q9 Quality Risk Management Guidelines. The final version has now been published.

GMP deficiencies are often identified during FDA inspections. Responding to an FDA deficiency report is important, otherwise a Warning Letter may be issued. But how should one respond?

Bracketing approaches are certainly allowed in the context of cleaning validation. First, for the products themselves, so that a "worst case" substance can be used for validation, second, for devices of the same design, the effort can be reduced by bracketing. In this way, a device can be selected. So how to define these "worst cases"? Read more here about FDA's view on this.

In the GMP rules there are many undefined terms, such as regular, adequate, etc. Inspection reports that interpret these undefined legal terms sometimes help here. In this case it is about insufficient process validation. What happened?