What is GxP?

1What GxP stands for.

GxP stands for good “x” practice, with the x replaced by the field the rules cover. The UK regulator, the MHRA, defines it as “Good ‘X’ Practice where ‘X’ is used as a collective term” for good distribution practice, good clinical practice, good laboratory practice, good manufacturing practice and good pharmacovigilance practice.¹ The European Medicines Agency calls the last of these good pharmacovigilance practices, or GVP.²

GxP is not a regulation in its own right. It names a family of practices, and each has its own legal basis in each jurisdiction. The MHRA describes its data integrity guidance as a resource “across all GxP sectors”,³ and says it should be read “in conjunction with the applicable regulations and the general guidance specific to each GXP”.¹

2The main GxPs and the rules behind them.

GMP is, in the WHO’s words, “that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use”.⁴ In the US, Part 210 says the drug CGMP regulations contain “the minimum current good manufacturing practice” for making, processing, packing or holding a drug, and that failing to comply renders the drug adulterated.⁵ In the EU, Directive (EU) 2017/1572 lays down the principles and guidelines of GMP for medicines for human use, and EudraLex Volume 4 holds the guidelines for interpreting them.⁶⁷

GLP covers in vivo or in vitro experiments in which test articles are studied prospectively “to determine their safety”. It excludes studies in human subjects, clinical studies and basic exploratory studies.⁸ Part 58 applies to studies that support applications for products FDA regulates, including human and animal drugs, medical devices, biological products and food and colour additives.⁸

GCP is “an international, ethical, scientific and quality standard for the conduct of trials that involve human participants”.⁹ In the EU, the principles and Annex 1 of E6(R3) came into effect on 23 July 2025, and Annex 2, on designs such as pragmatic and decentralised trials, takes effect on 15 January 2027.¹⁰ FDA issued E6(R3) as final guidance in September 2025.¹¹

The EU GDP guidelines apply to wholesale distributors, who must hold a wholesale distribution authorisation. A manufacturer that distributes its own products must comply with GDP as well.¹² EU GVP applies to marketing authorisation holders, EMA and the medicines regulators of the Member States.²

3What every GxP asks for.

The practices regulate different work, but they ask for the same kinds of control. The table compares the US GMP and GLP regulations with the principles of ICH GCP.¹³⁸⁹

4GxP data and computerised systems.

Every GxP depends on records, so data integrity runs through all of them. The MHRA defines it as “the degree to which data are complete, consistent, accurate, trustworthy, reliable” throughout the data life cycle, and says the organisation “needs to take responsibility for the systems used and the data they generate”. Moving from a computerised system to paper, or the other way, does not by itself remove the need for data integrity controls.¹

For systems that generate, amend or store GxP data, the MHRA says shared logins and generic user access should not be used. A system used only partly for GxP work, such as an MRP system that holds approved suppliers and stock status, still needs assessment and control of those parts. Systems are validated for their intended purpose, and vendor-supplied validation data “in isolation of system configuration and users intended use is not acceptable”.¹

In the US, 21 CFR Part 11 applies to records in electronic form kept under any of FDA’s records requirements, so it covers electronic records kept under Part 211 or Part 58.¹⁴ ICH E6(R3) asks that computerised systems used in trials be fit for purpose, for example “through risk-based validation, if appropriate”.⁹

5Which GxP rules apply to you.

The rules that apply follow the work you do and the markets you supply. A company that performs only some operations covered by the US drug CGMP regulations need only comply with the regulations for those operations. Production of an investigational drug for a phase 1 study is exempt from Part 211, though it remains subject to the statutory CGMP requirement, and the exemption ends once the drug has been made available for a phase 2 or phase 3 study or lawfully marketed.⁵

Practices often meet in one programme. ICH E6(R3) says investigational products used in a clinical trial should be manufactured in accordance with applicable GMP standards,⁹ so a trial sponsor works under GCP and GMP at once.

The MHRA’s data integrity guidance does not extend to medical devices.¹ In the US, the device CGMP requirements are in the Quality Management System Regulation, 21 CFR Part 820.¹⁵

6How it runs in Seal.

Seal runs laboratory, manufacturing and quality work on one record, with QMS, eBR, MES, ELN and LIMS on one platform configured from your procedures. Each record keeps its audit history and electronic signatures, with controls to support 21 CFR Part 11 and EU GMP Annex 11, and every change runs its tests before your team releases it. Regulatory and validation sets out how that fits GAMP 5, Part 11 and Annex 11.

The QMS blueprint covers deviations, CAPA, change control, documents, training, audits, suppliers, complaints and risk. No software alone makes an operation compliant: your quality system, configuration, procedures and training remain part of the assessment.