[ REGULATORY INTELLIGENCE ]

GxP Standards Library

214 regulatory standards decoded for practitioners across GMP, GCP, GLP, validation, quality systems, data integrity, lab systems, manufacturing, and inspection readiness.

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Cut by the discipline you own, then by whether the document is binding law or advice. The card carries the summary; the page carries scope, key requirements, and what an inspector looks for.

SPEQ decodes published standards. It does not reproduce them, and it does not determine which apply to you.

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WHAT THE LIBRARY IS MADE OF

Binding law reads differently from advice — the card’s left edge carries its family.
Binding law82
Guidance71
Consensus standard48
Compendial13
214 standards
Newest revision
ISO 14155:2026Clinical Investigation of Medical Devices for Human Subjects — Good Clinical PracticeISO 14155:2026 is the good clinical practice standard for clinical investigations of medical devices in human subjects, governing their design, conduct, recording and reporting. It protects the rights, safety and well-being of subjects and ensures the scientific validity of the data. Edition 4, published in March 2026, is the current version and supersedes ISO 14155:2020, which strengthened risk-based principles, ethics-committee and informed-consent detail, and alignment with ISO 14971. The standard is referenced by the EU Medical Device Regulation for clinical investigations and recognised by FDA for device clinical data. It is the device-world analogue of ICH E6, the GCP standard for medicinal-product trials.ISOREV. 2026HIGH RISK
FDA CSA Guidance (2026)Computer Software Assurance for Production and Quality Management System SoftwareFDA CSA Guidance is FDA's final guidance on Computer Software Assurance for production and quality management system software. The current version is dated February 2026 and supersedes the final guidance of the same subject issued 24 September 2025, which itself followed a 2022 draft; the title changed from "Quality System" to "Quality Management System" software, tracking the QMSR transition. Verified against FDA's guidance page on 2026-08-26. It sets a risk-based assurance framework for computers and automated data-processing systems used in medical-device production or the quality system under 21 CFR 820 and the QMSR. The guidance shifts effort from exhaustive documentation toward least-burdensome assurance driven by critical thinking, with testing proportionate to a feature's process risk — unscripted, ad-hoc or scripted. It supplements the 2002 General Principles of Software Validation and supersedes Section 6 of that document, covering on-premise and cloud systems.FDAREV. 2026HIGH RISK
ISO 17665:2024Sterilization of Health Care Products — Moist Heat — Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical DevicesFirst-edition ISO 17665:2024 consolidates and replaces ISO 17665-1:2006 and the two technical specifications (17665-2:2009 and 17665-3:2013) into a single document. It specifies requirements for developing, validating and routinely controlling a moist-heat (saturated steam) sterilization process for medical devices. The standard covers process and product definition, installation, operational and performance qualification, the use of physical measurement together with biological and chemical indicators, and ongoing maintenance of process effectiveness. It sits within the ISO healthcare-sterilization family alongside ISO 11135 (ethylene oxide) and ISO 11137 (radiation), under the general sterility framework of ISO 11139 and ISO 14937.ISOREV. 2024HIGH RISK
ISO 15189:2022Medical Laboratories — Requirements for Quality and CompetenceISO 15189:2022 is the accreditation standard for medical and clinical laboratories, specifying requirements for quality and competence. The fourth edition restructured the standard onto the ISO/IEC 17025 format, embedded a risk-based approach throughout, and brought point-of-care testing (POCT) into scope by absorbing the former ISO 22870. It sets general, structural, resource, process and management-system requirements across the total testing process — pre-examination, examination and post-examination. Accreditation bodies use it to accredit clinical laboratories, and it is distinct from ISO/IEC 17025, which covers testing and calibration laboratories generally. The standard centres on patient safety and the competence of the laboratory to deliver reliable results.ISOREV. 2022HIGH RISK
ISO 10993-1:2018Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management ProcessISO 10993-1:2018 is the cornerstone of the ISO 10993 biocompatibility series. Its fourth edition frames biological evaluation within the ISO 14971 risk-management process rather than as a fixed checklist of tests. It categorises devices by the nature and duration of body contact — surface, external-communicating or implant; limited, prolonged or long-term — and drives selection of biological endpoints such as cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation and haemocompatibility. It emphasises chemical characterisation (ISO 10993-18) and a documented biological evaluation plan and report. FDA recognises the 2018 edition alongside its 2020 guidance on using ISO 10993-1; a further revision (ISO 10993-1:2025) is in development.ISOREV. 2018HIGH RISK
Reg. (EU) 2017/1569Good Manufacturing Practice for Investigational Medicinal ProductsCommission Delegated Regulation (EU) 2017/1569, of 23 May 2017, specifies the principles and guidelines of good manufacturing practice for investigational medicinal products for human use and the arrangements for inspections. It supplements the Clinical Trials Regulation (EU) 536/2014 and applies from the date that Regulation became applicable, 31 January 2022. Together with the Detailed Commission Guidelines on GMP for IMPs in EudraLex Volume 4, it replaced the former EU GMP Annex 13, which was repealed. It covers the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, QP release, outsourcing, and complaints and recall, alongside IMP-specific challenges such as blinding and comparators.ECREV. 2017HIGH RISK
ISO 11135:2014Sterilization of Health-Care Products — Ethylene Oxide — Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical DevicesISO 11135:2014, with Amendment 1:2018 revising Annex E on single-batch release, specifies requirements for developing, validating and routinely controlling an ethylene-oxide (EO) sterilization process for medical devices in both industrial and healthcare-facility settings. It covers process and product definition, microbiological methods including the overkill and other bioburden-based approaches, installation, operational and performance qualification (IQ/OQ/PQ), and control of EO and ethylene-chlorohydrin residuals, which link to ISO 10993-7. A revision, ISO/FDIS 11135, is in progress but not yet published, so the 2014 edition with its 2018 amendment remains current.ISOREV. 2014HIGH RISK
WHO TRS 986, Annex 2WHO Good Manufacturing Practices for Pharmaceutical Products: Main PrinciplesWHO TRS 986, Annex 2 is the World Health Organization's main-principles Good Manufacturing Practices text for pharmaceutical products, published as Annex 2 of the 48th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations in Technical Report Series No. 986 (2014). It is the reference GMP standard underpinning the WHO Certification Scheme for products in international commerce and the WHO Prequalification programme. It covers the pharmaceutical quality system, personnel, premises and equipment, documentation, production, quality control, contract manufacture and analysis, complaints, recalls, and self-inspection, and is widely adopted by national regulators without their own detailed GMP.WHOREV. 2014HIGH RISK
ICH Q6BSpecifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological ProductsICH Q6B harmonises the specifications — the tests, analytical procedures, and acceptance criteria — that define quality for biotechnological and biological products such as proteins and polypeptides. It addresses the analytical challenges unique to biologics: inherent molecular heterogeneity, the need for orthogonal physicochemical and biological characterisation, potency measured by relevant bioassay, and the separation of product-related from process-related impurities. It sets expectations for well-qualified reference standards and materials. Q6B complements Q6A, which governs chemical drug substances and products, and forms the specification basis a marketing application in the ICH regions must justify.ICHREV. 1999HIGH RISK
COMPLETE INDEX — ALL 214 STANDARD

Every count on this page is derived from src/data/standards.ts at render — none is a literal. SPEQ curates and cross-references these sources; it is not affiliated with or endorsed by any of them.