Updated: Jun 26
Just a quick thought here.
Risk management, compiling risk assessments are with us for a while now. The first version of ICH Q9 was issued in 2005.
Almost all our processes are (or should be) established based on risk assessment, that can be either simple (like a classification of a deviation or a complaint) or complex (FMEA-analysis of a manufacturing process). However, let's not forget one simple, but very important element:
You cannot assess any risk of GMP requirement to omit it. GMP requirements are unavoidable if your process is in scope.