Glossary · GxP: good practices
GxP
Also known as: GxP regulations, Good practices (GxP), Good x practice
GxP is the umbrella term for the good practice regulations and guidelines that govern the development, testing, manufacture, distribution and monitoring of medicinal products, with the x standing for a specific field such as manufacturing (GMP), clinical (GCP) or laboratory (GLP). What unites them is the demand that quality, patient safety and data reliability be demonstrated by controlled processes and records.
- GxP
- Pharma
In one sentence
GxP is the umbrella term for good practice rules in pharma, such as GMP, GCP, GLP, GDP and GVP, each with its own legal sources and inspections.
Example
A contract development and manufacturing organization maps each of its departments to the applicable practices: the toxicology lab to GLP, the clinical supply unit to GMP and GCP, the warehouse to GDP, and the drug safety team to GVP.
How it applies
- Not one law: GxP has no single legal text. Each practice has its own sources, scope and inspectorate, and a company is bound only by the practices that match its activities.
- Common core: All practices ask for defined responsibilities, trained staff, written procedures, controlled changes and records that show what was done, by whom and when; see Data integrity (GxP) and ALCOA+.
- Computerized systems: Systems that create or hold GxP records must be validated for their intended use, in the EU under Annex 11 and in the USA under 21 CFR Part 11; GAMP 5 is the common industry guide.
- Medical devices: Device manufacturers work under a quality management system to ISO 13485 and, in the USA, the QMSR rather than under GMP by name. GxP applies to them where they supply pharma, run clinical investigations (ISO 14155) or make drug-device combinations.
- Technical documentation: “GxP-relevant” is a scoping decision that must be recorded: which processes, systems and records fall under which practice, and why.
Overview of the practices
| Practice | Scope | Main sources |
|---|---|---|
| GMP | Manufacture and quality control of medicinal products and active substances | EudraLex Volume 4, Directive (EU) 2017/1572, ICH Q7, 21 CFR Parts 210 and 211, PIC/S GMP guide |
| GDP | Wholesale distribution, storage and transport of medicinal products | EU Guidelines of 5 November 2013 (2013/C 343/01) |
| GLP | Non-clinical safety studies | OECD Principles of GLP (1997), Directive 2004/10/EC, 21 CFR Part 58 |
| GCP | Clinical trials with human participants | ICH E6(R3), Regulation (EU) No 536/2014, ISO 14155 for devices |
| GVP | Pharmacovigilance of authorized medicinal products | EMA GVP modules, Regulation (EC) No 726/2004, Directive 2001/83/EC, Implementing Regulation (EU) No 520/2012 |
| GEP | Engineering of equipment and facilities | ISPE Good Practice Guide: Good Engineering Practice, ASTM E2500 |
| GDocP | Creation, correction and retention of records across all practices | EU GMP Chapter 4, MHRA and PIC/S data integrity guidance |
GxP vs. ISO 13485
GxP is a family of mostly legally binding practices for medicinal products, enforced through inspections by medicines authorities. ISO 13485 is a voluntary quality management standard for medical devices that becomes the route to showing QMS requirements under the MDR, the IVDR and the FDA QMSR. The ideas overlap — validation, CAPA, document control — but the legal sources, terms and inspectors differ.