The "x" in GxP stands for the area of activity. The most common are Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and Good Pharmacovigilance Practice (GVP). In the US, GMP for medicines is set out in 21 CFR Part 211. In the EU, it's in the EU GMP guidelines (EudraLex Volume 4).
Why it matters for labeling
Labels and packaging are part of the product, so labeling falls under GMP. That covers how labeling is approved, printed, issued, and checked, and how the records of those steps are kept. Any computerized system used to make or support a labeling decision, including artwork comparison and proofreading software, is a GxP system. It needs validation, an audit trail, and controlled access, under 21 CFR Part 11 in the US and EU GMP Annex 11 in the EU.
Common mistakes
- Treating artwork review tools as "just software" outside the quality system, without validation
- Keeping review evidence in email or spreadsheets that can't meet audit trail expectations
- Assuming one framework, such as Part 11, covers every market