Glossary of Terms and Phrases - GxP Compliance Framework

Glossary of Terms and Phrases

Authored and Published By: The International Foundation for Information Technology (IF4IT), LLC

Term or Phrase	Abbreviation or Acronym	Definition
21 CFR 211.22	—	U.S. FDA regulation requiring the Quality Unit to be organizationally independent from Production under Good Manufacturing Practice — the source of the separation-of-duties principle applied throughout this Framework.
21 CFR Part 11	—	U.S. FDA regulation governing electronic records and electronic signatures, establishing requirements for tamper-evident audit trails in computerized GxP systems.
ALCOA+	ALCOA+	The nine-principle framework — Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available — used to evaluate whether a data record can be trusted as genuine evidence.
Audit Trail	—	A tamper-evident, chronological record — paper or electronic — capturing who performed a GxP-relevant action, when, and why.
Chain of Custody	—	The unbroken, documented record of who possessed and physically handled a sample or specimen at every point from collection through final disposition.
Codex Alimentarius Commission	—	The international body, jointly established by the FAO and WHO, that defines Good Hygiene Practice and related food-safety-adjacent standards.
Data Integrity	—	The GxP requirement that recorded data be complete, consistent, and accurate throughout its entire lifecycle, from creation through archiving or disposition.
Deviation	—	A documented instance where actual execution departed from a governing Standard Operating Procedure, requiring formal investigation and disposition.
Enterprise Knowledge Management	EKM	The organizational discipline of capturing, organizing, and retaining institutional knowledge; several GxP disciplines, particularly GDocP, serve this purpose secondarily beyond their primary regulatory function.
European Centre for the Validation of Alternative Methods	ECVAM	The body that originated Good Cell and Tissue Culture Practice (GCCP).
European Medicines Agency	EMA	The European Union’s regulatory body publishing and enforcing multiple GxP disciplines, including GMP, GDP, and GVP.
Food and Drug Administration	FDA	The U.S. regulatory body publishing and enforcing multiple GxP disciplines across nearly every domain in this Framework.
Good Agricultural and Collection Practice	GACP	Governs cultivation, harvesting, and collection of medicinal plants and herbal starting materials to ensure raw material purity.
Good Auditing Practice	GAP	Governs internal and vendor compliance audits verifying adherence to other GxP disciplines.
Good Automated Manufacturing Practice	GAMP	A risk-based lifecycle framework for validating automated machinery, enterprise software, and IT infrastructure in regulated manufacturing.
Good Cell and Tissue Culture Practice	GCCP	Governs growth, handling, and maintenance of living cell and tissue cultures to prevent contamination and ensure reproducible research data.
Good Clinical Data Management Practice	GCDMP	Governs Electronic Data Capture system design, real-time data recording, and database locking for regulatory submission.
Good Clinical Laboratory Practice	GCLP	A hybrid standard combining GLP’s data-integrity discipline and GCP’s subject-protection principles for laboratories analyzing clinical trial samples.
Good Clinical Practice	GCP	Governs the design, conduct, recording, and reporting of human clinical trials.
Good Computational Practice	GCP	Governs validation and reproducibility of computational modeling, molecular simulation, and in silico research methods.
Good Distribution Practice	GDP	Governs the secure wholesale movement of pharmaceutical products from manufacturer to point of sale.
Good Documentation Practice	GDocP	Establishes non-negotiable ALCOA+ documentation rules for paper and electronic records across every department.
Good Engineering Practice	GEP	Governs facility and utility qualification, including water systems, HVAC cleanrooms, and processing equipment.
Good Experimental Practice	GEP	Governs structured experimental design and environmental controls for early-stage, non-regulated exploratory laboratory research.
Good Hygiene Practice	GHP	Enforces environmental sanitation, pest control, and personnel hygiene in early-stage material handling areas.
Good Machine Learning Practice	GMLP	Governs the development, deployment, and monitoring of AI- and machine-learning-enabled medical devices throughout their lifecycle.
Good Manufacturing Practice	GMP	Governs full-scale commercial batch production, quality control laboratory testing, and cleaning validation.
Good Pharmacoepidemiology Practice	GPP	Governs observational, population-level studies assessing a product’s real-world outcomes after approval.
Good Pharmacovigilance Practice	GVP	Governs post-market safety surveillance and adverse event reporting throughout a product’s lifecycle; also called Good Vigilance Practice in some jurisdictions.
Good Pharmacy Practice	GPP	Governs dispensing safety, compounding controls, and patient-facing standards at retail and clinical pharmacies.
Good Quality Practice	GQP	Governs the overall Quality Management System, CAPA programs, and risk frameworks under Japan’s Pharmaceutical Affairs Law.
Good Storage Practice	GSP	Governs the quality-assurance controls required to maintain product integrity throughout warehousing.
Good Tissue Practice	GTP	Governs recovery, donor screening, processing, and storage of human cells and tissue-based products.
Good Trade and Distribution Practice	GTDP	Governs quality-assurance controls throughout international trade and cross-border distribution.
Good x Practice	—	The variable-discipline naming template underlying every GxP discipline: “Good,” a specific practice area, and “Practice,” each instance defined by one or more regulatory bodies.
Governance, Risk, and Compliance	GRC	An integrated system approach connecting discipline ownership to associated SOPs, audit findings, and CAPA records.
GxP	GxP	The umbrella acronym for the entire “Good x Practice” family of disciplines, governed by different regulatory bodies rather than a single unified standard.
GxP Access Governance	—	The practice of granting, reviewing, and revoking system and data access specifically calibrated to GxP’s Attributable and Traceable requirements, ensuring every action is traceable to a specific, authorized individual.
GxP Product Lifecycle	—	The full, connected chain of GxP-governed activity across a regulated product’s existence, treated as one system rather than independent domains.
GxP-Relevant Application	—	An application whose function directly creates, stores, processes, or transmits evidence a GxP discipline depends on, regardless of which business function operates it.
GxP-Scoped Data and Information	—	Data or information whose accuracy, completeness, and integrity a specific GxP discipline depends on for compliance, as distinct from data an enterprise holds that carries no GxP relevance.
Health Canada	—	Canadian federal regulatory body; co-published Good Machine Learning Practice alongside the FDA and the UK’s MHRA.
Horizontal Governance Domain	—	A domain, such as Cross-Functional Operations and Business Governance, that spans and oversees all sequential domains continuously rather than occupying one stage of the lifecycle.
Independent Ethics Committee	IEC	The globally-used term for the ethics oversight body governing human clinical trials under Good Clinical Practice; the U.S.-specific equivalent is the IRB.
Institutional Review Board	IRB	The U.S.-specific term for the ethics oversight body governing human clinical trials under Good Clinical Practice.
International Council for Harmonisation	ICH	The body that harmonizes GxP guidance — including ICH E6 (Good Clinical Practice) and ICH Q7 (Good Manufacturing Practice for active pharmaceutical ingredients) — across the FDA, EMA, and other member regulators.
International Pharmaceutical Federation	FIP	The body that jointly publishes Good Pharmacy Practice with the WHO.
International Society for Pharmaceutical Engineering	ISPE	The body that publishes Good Automated Manufacturing Practice and Good Engineering Practice guidance — distinct from the International Society for Pharmacoepidemiology, despite sharing the same abbreviation.
International Society for Pharmacoepidemiology	ISPE	The body that publishes Good Pharmacoepidemiology Practice — distinct from the International Society for Pharmaceutical Engineering, despite sharing the same abbreviation.
Investigational Medicinal Product	IMP	A product manufactured at smaller, non-commercial scale specifically for use in clinical trials, governed by GMP requirements scaled for investigational realities.
Laboratory Information Management System	LIMS	A system supporting laboratory sample tracking and results management, commonly relevant to Good Clinical Laboratory Practice and Good Manufacturing Practice’s quality control testing.
Medicines and Healthcare products Regulatory Agency	MHRA	The United Kingdom’s regulatory body; co-publisher of GCLP guidance and, alongside the FDA and Health Canada, Good Machine Learning Practice.
Ministry of Health, Labour and Welfare	MHLW	The Japanese government ministry enforcing Good Quality Practice under the Pharmaceutical Affairs Law.
Pharmaceuticals and Medical Devices Agency	PMDA	The Japanese regulatory agency enforcing Good Quality Practice alongside the MHLW.
RACI Matrix	RACI	A responsibility-assignment matrix (Responsible, Accountable, Consulted, Informed) used to document ownership across GxP disciplines.
Research Quality Association	RQA	The body that originated Good Clinical Laboratory Practice.
Role-Based Access Control	RBAC	An access-management approach assigning system permissions based on defined roles rather than individuals, applied to GxP-relevant systems to help enforce Attributability and least-privilege access.
Separation of Duties	—	The GxP principle that the function producing or executing work should be organizationally independent from the function certifying its compliance.
Sequential Domain	—	One of the four domains that follow the literal physical and temporal path a regulated product takes: R&D, Clinical Development, Manufacturing, and Supply Chain.
Society for Clinical Data Management	SCDM	The industry professional body that maintains Good Clinical Data Management Practices.
Standard Operating Procedure	SOP	A documented, step-by-step set of instructions governing how a specific critical workflow must be performed.
Traceability	—	The ability to trace any GxP-relevant batch, sample, test result, or decision back to who performed it, when, and why.
True Copy	—	A certified duplicate of an original record, verified to be an exact and complete reproduction, recognized by GxP as an acceptable substitute for the original.
Water for Injection	WFI	A high-purity water system requiring qualification under Good Engineering Practice, used in pharmaceutical manufacturing.
World Health Organization	WHO	A globally influential body publishing guidance across numerous GxP disciplines, including GACP, GSP, GTDP, GHP, and GPP.

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