GxP

What the x covers

Regime	Scope	Anchor
GMP	Manufacture of drug substance and product	21 CFR 210/211, EudraLex Vol. 4
GCP	Design and conduct of clinical trials	ICH E6
GLP	Non-clinical safety studies	21 CFR 58, OECD GLP
GDP	Storage and distribution	EU GDP Guidelines
GVP	Pharmacovigilance	EU GVP Modules

What they share

Each regime governs a different activity, but they rest on the same three ideas. Decisions must be documented well enough to be reconstructed years later by someone who was not there. Systems that produce regulated data must be validated. And the quality function must be able to say no without commercial override.

This is why GxP is useful as a single word: an organisation is rarely strong in one and weak in another by accident. The failures are cultural before they are technical.

Why it matters for software

A system is "GxP" not because of what it is but because of what it touches. A spreadsheet calculating a batch yield is in scope; the same spreadsheet tracking office supplies is not. Scope follows the predicate rule — the underlying regulation that requires the record to exist.

That determination drives everything downstream: validation effort, 21 CFR Part 11 controls, retention, and change management. Getting it wrong in either direction is costly. Over-scoping validates systems nobody needed to validate; under-scoping is a finding.