GxP compliance is an umbrella term for meeting applicable Good Practice requirements across regulated life-sciences activities. Examples include Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, and Good Distribution Practice.
Although the governing requirements differ by activity and jurisdiction, recurring principles include protection of patients and product quality, data integrity, traceability, accountability, qualified personnel, controlled processes, and reliable records.
Computerized systems relied upon to support GxP processes should be assessed to determine their regulatory impact and the controls and assurance activities appropriate to their intended use and risk.
Depending on the regulated activity and jurisdiction, additional requirements may apply to electronic records, electronic signatures, computerized systems, and data integrity. Examples include FDA 21 CFR Part 11 and EU GMP Annex 11 when their respective scope criteria are met.
Noncompliance can result in inspection observations, warning letters, corrective actions, market restrictions, or other enforcement measures available to the responsible authority. More fundamentally, GxP controls support confidence that regulated products and associated records are reliable.
Frequently Asked Questions
What does the x in GxP stand for?
The “x” is a placeholder for the relevant Good Practice discipline, such as Manufacturing, Laboratory, Clinical, or Distribution. GxP is shorthand for the broader family of regulated Good Practice requirements.
What makes a system a GxP system?
Its intended use and regulatory impact, not its technology. A system may be considered GxP-relevant when it is relied upon for a regulated process, record, decision, calculation, or control that can affect patient safety, product quality, data integrity, or compliance.
How does GxP compliance relate to 21 CFR Part 11?
Applicable predicate rules define required activities and records. Part 11 establishes conditions for electronic records and electronic signatures within its scope. Part 11 does not apply merely because a system is electronic or used by a life-sciences company.
Who enforces GxP compliance?
The responsible authorities depend on the product, activity, and jurisdiction. Examples include the FDA in the United States, competent national authorities within the EU regulatory framework, the MHRA in the United Kingdom, and the PMDA in Japan.