Regulatory glossary

What Is GxP? The Good Practice Regulations, Explained

GxP is the umbrella term for the good practice regulations and guidelines that govern how life sciences work is done. The x is a placeholder: swap it for the discipline and you get GMP for manufacturing, GLP for non-clinical laboratory studies, GCP for clinical trials, and so on.

They exist to answer one question a regulator asks of any submission: can this evidence be trusted? Not just whether the product is safe and effective, but whether the records demonstrating it were generated under conditions that make them believable.

The main GxP disciplines

Two more you will hear that are not regulations:

• GAMP 5 is an ISPE guide to validating computerised systems. Widely used, frequently cited, not legally binding.
• cGMP is GMP with a "current" in front. The lower-case c is deliberate and it does real work: it means the expectation moves as technology and industry practice move. What passed an inspection in 2015 is not automatically enough now.

Medical devices: 21 CFR 820 became the QMSR in February 2026

Device quality has its own track, and it changed recently enough that a lot of material online is out of date.

Since 2 February 2026, FDA's Quality System Regulation has been replaced by the Quality Management System Regulation (QMSR). Part 820 now incorporates ISO 13485:2016 by reference rather than restating requirements in its own words, plus FDA-specific additions retained in Subparts A and B.

The practical effect: Part 820 is much shorter, and for most requirements it points you at the corresponding clause of ISO 13485 instead of spelling it out. If a guide you are reading walks through Part 820 subpart by subpart with its own text for design controls and CAPA, it is describing the pre-2026 regulation.

What GxP compliance actually requires

Across every discipline the same expectations recur.

Written procedures, followed. An SOP that describes something other than what people do is worse than no SOP, because the gap is documented.

Records that show what happened. Contemporaneous, attributable, and complete enough that someone who was not there can reconstruct the event.

Trained people. Training records are among the first things an investigator asks for.

Qualified equipment and validated systems. Including software: if a computerised system holds GxP records, it falls under 21 CFR Part 11.

Deviations investigated, not just logged. A deviation without a root cause and a CAPA is an open finding waiting to be written up.

Change control. Every change assessed for its effect on product quality and on what you have already told the agency.

ALCOA+ : the data integrity test

Regulators assess GxP records against a shorthand called ALCOA, extended to ALCOA+:

• Attributable — you can tell who did it, and when
• Legible — readable, and permanent
• Contemporaneous — recorded as it happened, not reconstructed later
• Original — the first capture, or a verified true copy
• Accurate — correct, and consistent with the rest of the record

Plus: Complete, Consistent, Enduring, Available.

Most data integrity findings are ALCOA failures with a specific name. Backdating a log breaks contemporaneous. A shared login breaks attributable. An audit trail that can be switched off breaks original. Reading a Form 483 or a warning letter with ALCOA in mind makes the findings much easier to anticipate in your own systems.

Who enforces GxP

• FDA inspects US facilities and foreign sites shipping to the US, issuing Form 483 observations, warning letters, import alerts and, at the far end, consent decrees.
• EMA and EU national authorities run their own GMP and GCP inspections and issue EudraGMDP statements of non-compliance.
• MHRA, TGA, PMDA, Health Canada and others inspect within their own jurisdictions, with a growing amount of mutual recognition.

An FDA inspection outcome is not confined to one site. A facility problem at a contract manufacturer can become an approvability issue on your application, which is how a GMP finding turns into a Complete Response Letter.