About once a year, I find the need to criticize the GAMP5 writing teams for their use of terms. Seriously, change the name already.
This year’s rant is triggered by reading a good practices guide designed to be pan-GxP and getting frustrated by its utter GMP focus. I knew I was in trouble when it specifically discussed “Product and Process Understanding” as a critical factor and then referenced ICH Q10. Use those terms with ICH Q10, and you just announced to the entire world that this is a GMP book. It is important to use a wider term and then reference product/process understanding as one subcategory or way of meeting it.
I rather like the approach of ICH E6 and E8 here, which is to use the wider term “Critical to Quality,” which in the broader sense can be expanded to mean the key factors that must be controlled or monitored to ensure the quality, safety, and efficacy of pharmaceutical products from development to clinical studies to manufacturing and distribution and beyond. It’s a risk-based approach focused on what matters most for patient safety and reliable results.
Investigations of a Dog 