GAMP – Good Automated Manufacturing Practices


Hello good people of the world! What, another acronym?! Yes, we love ’em!

GAMP = Good Automated Manufacturing Practices is a term coined by ISPE and their associated JETT consortium. GAMP focuses on automation and control systems, i.e. computer software and hardware. GAMP is one response to FDA’s 21CFR11.

One of GAMP’s most recognizable contributions to automation validation is the so-called V-model, which takes many forms but perhaps in it’s simplest is below:

V model

Another highlight from the guidance is the categorization of software, which looks something like:

Category 1: Operating systems
Category 2: Firmware
Category 3: Standard software
Category 4: Configured software
Category 5: Custom software

As you go up in category, the level of specification testing detail goes up.

GAMP is the de facto standard for Computer System Validation (CSV) in the industry currently, providing a solid foundation for any CSV program.

What are your thoughts on GAMP? Leave a comment below and please share this post with whomever you think would benefit.