GAMP5 is pretty clear in its ambition:

This Guide applies to computerized systems used in regulated activities covered by:

•Good Manufacturing Practice (GMP) (pharmaceutical, including Active Pharmaceutical Ingredient (API), veterinary, and blood)

•Good Clinical Practice (GCP)

•Good Laboratory Practice (GLP)•Good Distribution Practice (GDP)

•Good Pharmacovigilance Practices (GVP)

•Medical Device Regulations (where applicable and appropriate, e.g., for systems used as part of production or the quality system, and for some examples of Software as a Medical Device (SaMD1))

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (2nd edition),

The biggest problem with GAMP is when you search GAMP you get:

That’s right, the ISPE telling you that GAMP is all about manufacturing. A point that Wikipedia is more than happy to reinforce: https://en.wikipedia.org/wiki/Good_automated_manufacturing_practice

This means that I spend a lot of time explaining why GAMP is relevant outside of manufacturing, to a lot of skeptical people who already struggle with the idea that GCP or GLP isn’t some special and unique flower.

To add to that, it is structured like a GxP. I see a G-some letters-P I instantly think Good <something> Practices. It is how my brain and the brain of every single person who works in the GxPs have been trained.

Second, what is that 5? What does it mean? It’s such a bit of esoteric lore that I have to spend more time explaining. For absolutely no value.

And then last, I inevitably have to deal with skepticism about something published by the International Society of Pharmaceutical Engineering being even remotely relevant to the work a study investigator is doing.

Without a doubt, GAMP is a powerful methodology and toolbox. It just shoots itself in the foot every time. It is unfortunate that with the 2nd edition the ISPE did not take a big breath and successfully rebrand as maybe GDIP or something.