Directive (EU) 2017/1572
1 entryPrinciples and guidelines of good manufacturing practice for medicinal products
Norms and regulations
Glossary entries name the standard or legal act that defines them. This index collects those references in one place — from ISO 12100 and IEC 61508 to the AI Act and 21 CFR Part 11 — so you can start from a norm and find every term that depends on it.
The index is compiled automatically from the reference field of each glossary entry and grows with the glossaries. It shows where a document is cited, not whether it applies to your product: naming a standard or law never implies compliance, and status and dates are stated in the entries themselves.
Regulations, directives, decisions and the EU guidance they rely on
Principles and guidelines of good manufacturing practice for medicinal products
NIS 2 Directive (NIS2)
Glossary entry: NIS 2 DirectiveATEX workplace directive (ATEX 137)
Community code relating to medicinal products for human use
Good Laboratory Practice Directive (GLP Directive)
Restriction of Hazardous Substances Directive (RoHS)
Glossary entry: RoHSElectromagnetic Compatibility Directive (EMC Directive)
Low Voltage Directive (LVD)
Glossary entry: Low Voltage DirectiveGood pharmacovigilance practices (GVP)
Glossary entry: Good pharmacovigilance practices (GVP)Manufacture of sterile medicinal products
Glossary entry: EU GMP Annex 1 (sterile medicinal products)Computerised systems
Glossary entry: EU GMP Annex 11 (computerized systems)Qualification and validation
Glossary entry: EU GMP Annex 15 (qualification and validation)Certification by a Qualified Person and batch release
Artificial intelligence (draft)
Cited as EudraLex Volume 4, draft Annex 22 (July 2025)
Glossary entry: EU GMP Annex 22 (artificial intelligence, draft)EU guidelines for good manufacturing practice (EU GMP)
Cited as EudraLex Volume 4 Part II · EudraLex Volume 4, Part I, Chapter 1 · EudraLex Volume 4, Part I, Chapter 4
Guidelines on good distribution practice of medicinal products for human use (GDP)
Pharmacovigilance Implementing Regulation
Medical Device Regulation (MDR)
Glossary entry: Medical Device Regulation (MDR)In Vitro Diagnostic Medical Devices Regulation (IVDR)
Glossary entry: In Vitro Diagnostic Medical Devices Regulation (IVDR)Machinery Regulation
Glossary entry: Machinery Regulation (EU) 2023/1230Batteries Regulation
Artificial Intelligence Act (AI Act)
Glossary entry: EU AI ActEcodesign for Sustainable Products Regulation (ESPR)
Glossary entry: Ecodesign for Sustainable Products Regulation (ESPR)Cyber Resilience Act (CRA)
Glossary entry: Cyber Resilience Act (CRA)Clinical Trials Regulation
Regulation on European standardisation
Federal statutes, the Code of Federal Regulations, executive orders, state laws and FDA guidance
Electronic records; electronic signatures
Glossary entry: 21 CFR Part 11 (electronic records and signatures)Good laboratory practice for nonclinical laboratory studies
Current good manufacturing practice in manufacturing, processing, packing or holding of drugs
Current good manufacturing practice for finished pharmaceuticals
Establishment registration and device listing, premarket notification
Premarket approval of medical devices
Quality Management System Regulation (QMSR)
Glossary entry: Quality Management System Regulation (QMSR, 21 CFR Part 820)Unique device identification
Glossary entry: Unique Device Identification (UDI)Occupational safety and health standards (OSHA)
Cited as 29 CFR 1910.147 · 29 CFR 1910.212
Transparency in Frontier Artificial Intelligence Act
Glossary entry: California SB 53 (Transparency in Frontier AI Act)Colorado AI Act
Glossary entry: Colorado AI ActRemoving Barriers to American Leadership in Artificial Intelligence
Glossary entry: Executive Order 14179Federal Food, Drug, and Cosmetic Act (FD&C Act)
Cited as FD&C Act sections 510(k), 513(f)(2) and 515 · Section 515C FD&C Act
Federal bills and Treasury Board directives
Artificial Intelligence and Data Act (AIDA)
Cited as Part 3 of Bill C-27 (44th Parliament)
Glossary entry: Artificial Intelligence and Data Act (AIDA)Administrative measures and provisions on AI services
Cited as 算法备案
Glossary entry: Algorithm filing (China)Cited as 生成式人工智能服务管理暂行办法
Cited as 人工智能生成合成内容标识办法
Cited as 互联网信息服务深度合成管理规定
ISO, IEC, joint ISO/IEC/IEEE standards, JCGM, OIML and ITU-T
Cited as IEC 60034-1
International Electrotechnical Vocabulary
Cited as IEC 60050-131 · IEC 60050-192 · IEC 60050-351
Explosive atmospheres
Cited as IEC 60079-11
Safety of machinery — Electrical equipment of machines
Cited as IEC 60204-1
Glossary entry: IEC 60204-1Cited as IEC 60269-1
Cited as IEC 60364-4-41
Cited as IEC 60381-1 · IEC 60381-2
Degrees of protection provided by enclosures (IP code)
Cited as IEC 60534-2-1
Cited as IEC 60584-1
Medical electrical equipment
Cited as IEC 60601-1:2005+A1:2012+A2:2020
Glossary entry: IEC 60601-1Failure modes and effects analysis (FMEA and FMECA)
Cited as IEC 60812:2018
Cited as IEC 60825-1
Cited as IEC 60898-1
Low-voltage switchgear and controlgear
Cited as IEC 60947-4-1 · IEC 60947-5-1 · IEC 60947-5-2 · IEC 60947-5-6 · IEC 60947-7-1
Cited as IEC 61000-4-30
Glossary entry: IEC 61000Cited as IEC 61008-1
Fault tree analysis (FTA)
Cited as IEC 61025:2006
Glossary entry: Fault Tree Analysis (FTA)Cited as IEC 61082-1
Programmable controllers
Cited as IEC 61131-2 · IEC 61131-3 · IEC 61131-9
Glossary entry: IEC 61131Industrial communication networks — Fieldbus specifications
Cited together with IEC 61784
Cited together with IDTA 01001
Cited together with IDTA 02006
Low-voltage switchgear and controlgear assemblies
Cited as IEC 61439-1
Safety of machinery — Electro-sensitive protective equipment
Cited as IEC 61496-1 · IEC 61496-2 · IEC 61496-3
Glossary entry: IEC 61496Function blocks
Cited as IEC 61499-1 · IEC 61499-4
Glossary entry: IEC 61499Functional safety of electrical/electronic/programmable electronic safety-related systems
Cited as IEC 61508-1:2010 · IEC 61508-2:2010 · IEC 61508-4:2010 · IEC 61508-6:2010 · IEC 61508:2010
Glossary entry: IEC 61508Functional safety — Safety instrumented systems for the process industry sector
Cited as IEC 61511-1:2016
Glossary entry: IEC 61511Batch control
Cited as IEC 61512-1 · IEC 61512-4
Cited together with ISA-88
Glossary entry: Batch controlIndustrial networks — Profiles
Cited as IEC 61784-1 · IEC 61784-2 · IEC 61784-3 · IEC 61784-3-3 · IEC 61784-3-12 · IEC 61784-3-13
Cited together with IEC 61158
Adjustable speed electrical power drive systems
Cited as IEC 61800-2 · IEC 61800-5-2 · IEC 61800-5-2:2016 · IEC 61800-7 · IEC 61800-7-201
Glossary entry: IEC 61800-5-2Cited as IEC 61804-3
Cited as IEC 61810-1 · IEC 61810-3
Communication networks and systems for power utility automation
Hazard and operability studies (HAZOP studies)
Cited as IEC 61882:2016
Cited as IEC 62026-2 · IEC 62026-3
Safety of machinery — Functional safety of safety-related control systems
Cited as IEC 62061:2021
Glossary entry: IEC 62061Enterprise-control system integration
Cited as IEC 62264-1 · IEC 62264-3
Cited together with ISA-95
Glossary entry: IEC 62264Medical device software — Software life cycle processes
Cited as IEC 62304:2006+A1:2015
Glossary entry: IEC 62304Medical devices — Application of usability engineering to medical devices
Cited as IEC 62366-1:2015+A1:2020
Glossary entry: IEC 62366-1Cited as IEC 62439-2
Security for industrial automation and control systems
Cited as IEC 62443-2-1 · IEC 62443-2-4 · IEC 62443-3-2 · IEC 62443-3-3 · IEC 62443-4-1 · IEC 62443-4-2
Glossary entry: IEC 62443OPC Unified Architecture
Cited as IEC 62541-2 · IEC 62541-3 · IEC 62541-4
Cited together with OPC 10000
Glossary entry: OPC Unified Architecture (OPC UA)Management of alarm systems for the process industries
Cited together with ISA-18.2
Engineering data exchange format (AutomationML)
Cited together with ISA-100.11a
Asset Administration Shell for industrial applications
Cited as IEC 63278-1
Cited together with IDTA 01001
Health software and health IT systems safety, effectiveness and security
Cited as IEC 81001-5-1:2021
Glossary entry: IEC 81001-5-1Cited together with DIN SPEC 91345
Cited as ISO 3691-4
Cited as ISO 5167-2
Cited as ISO 6983-1
Cited as ISO 7870-2
Robotics — Vocabulary
Cited as ISO 8434-1
Cited as ISO 8573-1
Quality management systems — Fundamentals and vocabulary
Cited as ISO 9000:2015
Ergonomics of human-system interaction
Cited as ISO 9241-11
Cited as ISO 9409-1
Quality management — Guidelines for configuration management
Cited as ISO 10007:2017
Robotics — Safety requirements
Cited as ISO 10218-1 · ISO 10218-2
Glossary entry: ISO 10218-1Cited as ISO 10628-1
Cited together with ISA-5.1
Biological evaluation of medical devices
Cited as ISO 10993-1
Glossary entry: ISO 10993-1Cited as ISO 11135:2014
Cited as ISO 11137-1:2006
Road vehicles — Controller area network (CAN)
Cited as ISO 11898-1
Safety of machinery — General principles for design — Risk assessment and risk reduction
Cited as ISO 12100:2010
Glossary entry: ISO 12100Cited as ISO 13381-1
Medical devices — Quality management systems
Cited as ISO 13485:2016
Glossary entry: ISO 13485Safety of machinery — Safety-related parts of control systems
Cited as ISO 13849-1:2023 · ISO 13849-2:2012
Glossary entry: ISO 13849-1Safety of machinery — Emergency stop function
Cited as ISO 13850:2015
Glossary entry: ISO 13850Safety of machinery — Positioning of safeguards with respect to approach speeds
Glossary entry: ISO 13855Cited as ISO 13856-2:2013
Safety of machinery — Prevention of unexpected start-up
Cited as ISO 14118:2017
Safety of machinery — Interlocking devices associated with guards
Glossary entry: ISO 14119Safety of machinery — Guards
Glossary entry: ISO 14120Clinical investigation of medical devices for human subjects — Good clinical practice
Cited as ISO 14155:2020
Glossary entry: ISO 14155Cleanrooms and associated controlled environments
Cited as ISO 14644-1:2015
Glossary entry: ISO 14644-1Medical devices — Application of risk management to medical devices
Cited as ISO 14971:2019
Glossary entry: ISO 14971Medical laboratories — Requirements for quality and competence
Cited as ISO 15189:2022
Glossary entry: ISO 15189Medical devices — Symbols to be used with information to be supplied by the manufacturer
Cited as ISO 15223-1:2021
Glossary entry: ISO 15223-1Cited as ISO 16484-5
Cited together with ASHRAE 135
Medical devices — Information to be supplied by the manufacturer
Cited as ISO 20417:2021
Glossary entry: ISO 20417Cited as ISO 20916:2019
Glossary entry: ISO 20916Business continuity management systems
Cited as ISO 22400-2
Occupational health and safety management systems
Cited as ISO 45001:2018
Energy management systems
Glossary entry: ISO 50001Cited together with ISO/IEC 22989
Cited as ISO/IEC 9834-8
Cited together with RFC 9562
Cited as ISO/IEC 15909-1
Artificial intelligence concepts and terminology
Cited together with ISO/IEC 5338
Data quality model
Information security management systems
Cited as ISO/IEC 27001:2022
Vulnerability disclosure
Glossary entry: Vulnerability disclosureArtificial intelligence — Management system
Cited as ISO/IEC/IEEE 15026-2:2022
Systems and software engineering — System life cycle processes
Cited as ISO/IEC/IEEE 24748-4
Systems and software engineering — Vocabulary
Software and systems engineering — Software testing
Cited as ISO/IEC/IEEE 29119-3
Systems and software engineering — Requirements engineering
Cited as ISO/IEC/IEEE 29148:2018
Software, systems and enterprise — Architecture description
Cited as ISO/IEC/IEEE 42010:2022
Robots and robotic devices — Collaborative robots
Glossary entry: ISO/TS 15066Guide to the expression of uncertainty in measurement (GUM)
International vocabulary of metrology (VIM)
EN, DIN, VDI/VDE, NAMUR, German technical rules and Chinese GB standards
Cited together with EN 13306
Cited as DIN 69901-5
Cited together with IEC PAS 63088
Cited together with DIN 31051
Cited as EN 18219:2026
Cited as EN 18220:2026
Cited as EN 18239:2026
Cited as EN 18246:2026
Cited as EN 50325-4
Cited as GB 45438:2025
ISA, IEEE, ANSI, ASTM, NIST, TIA and ASHRAE
BACnet — A data communication protocol for building automation and control networks
Cited together with ISO 16484
Specification, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment
Cited together with OPC 10000
Port-based network access control
Wireless LAN
Cited as IEEE 802.11ax
Low-rate wireless networks
Precision Time Protocol (PTP)
Cited as IEEE 1588:2019
Glossary entry: Precision Time Protocol (PTP)Cited together with ISO 10628
Management of alarm systems for the process industries
Cited together with IEC 62682
Glossary entry: ISA-18.2Batch control
Cited together with IEC 61512
Glossary entry: ISA-88Enterprise-control system integration
Cited together with IEC 62264
Glossary entry: ISA-95Cited together with IEC 62734
Human machine interfaces for process automation systems
AI Risk Management Framework (AI RMF)
The NIST definition of cloud computing
Zero trust architecture
Glossary entry: Zero trust architecture (ZTA)Cited as TIA-485-A
Internet RFCs, ECMA, OPC Foundation, OMG, OASIS, IDTA and fieldbus consortia
ECMAScript language specification
The JSON data interchange syntax
Cited together with RFC 8259
Cited together with IEC 61406
Cited as Modbus Application Protocol Specification · Modbus Messaging on TCP/IP Implementation Guide · Modbus over Serial Line Specification
Cited together with OMG UML
Cited together with OMG SysML
OPC Unified Architecture
Cited as OPC 10000-2 · OPC 10000-3 · OPC 10000-4 · OPC 10000-6 · OPC 10000-12 · OPC 10000-14 · OPC 10000-80 · OPC 10000-81
Cited together with IEC 62541, IEEE 802.1
Glossary entry: OPC Unified Architecture (OPC UA)Uniform Resource Identifier (URI): generic syntax
Network Time Protocol version 4 (NTP)
The JSON data interchange format
Cited together with ECMA-404
HTTP semantics
Universally unique identifiers (UUIDs)
Cited together with ISO/IEC 9834
Cited as Semantic Versioning 2.0.0
Glossary entry: Semantic versioningICH guidelines, PIC/S, WHO, MHRA and ISPE good practice guides
Good clinical practice
Cited as ICH E6(R3)
Glossary entry: ICH E6(R3) (good clinical practice)Common Technical Document (CTD)
Glossary entry: Common Technical Document (CTD, ICH M4)Validation of analytical procedures
Cited as ICH Q2(R2)
Good manufacturing practice for active pharmaceutical ingredients
Glossary entry: ICH Q7 (GMP for active pharmaceutical ingredients)Pharmaceutical development
Cited as ICH Q8(R2)
Glossary entry: ICH Q8(R2) (pharmaceutical development)Quality risk management
Cited as ICH Q9(R1)
Glossary entry: ICH Q9(R1) (quality risk management)Pharmaceutical quality system
Glossary entry: ICH Q10 (pharmaceutical quality system)Pharmaceutical product lifecycle management
Glossary entry: ICH Q12 (product lifecycle management)Analytical procedure development
Good Automated Manufacturing Practice
Glossary entry: GAMP 5