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Regulations and guidance

What is the difference between GLP, GMP and GCP?

GLP, GMP and GCP are the quality rules for three kinds of regulated work. Good laboratory practice governs nonclinical safety studies, such as the toxicology behind an IND, under 21 CFR Part 58 and the OECD principles. Good manufacturing practice governs making and testing the product, trial supplies included. Good clinical practice governs trials in people, under ICH E6(R3) and, for US drugs, 21 CFR Parts 50, 56 and 312. The purpose of the work decides which applies.

Illustration of a seal beside an open evidence folio containing SOP, training and execution records.

1GLP, GMP and GCP side by side.

Table 1. The rules for each practice in the US, EU and UK.
GLPGMPGCP
GovernsNonclinical studies of a test article’s safety¹Manufacture, processing, packing and holding of drugs²Trials that involve human participants³
AccountableThe study director, “the single point of study control”, checked by a separate QA unit¹US: the quality control unit. EU: a Qualified Person certifies each batch⁴⁵The sponsor and the investigator, with IRB or ethics committee review⁶⁷
Core recordsProtocol, raw data, final report with the QA statement¹Batch production and control record⁴Protocol, consent, case histories, trial master file⁸⁶⁹
US rules21 CFR Part 5821 CFR Parts 210 and 21121 CFR Parts 50, 56 and 312; FDA’s E6(R3) guidance¹⁰
EU rulesDirectives 2004/9/EC and 2004/10/EC, applying the OECD principles¹¹¹²Directive (EU) 2017/1572; EudraLex Volume 4¹³¹⁴Regulation (EU) No 536/2014; ICH E6(R3)⁹¹⁵
UK rulesGood Laboratory Practice Regulations 1999¹⁶Human Medicines Regulations 2012¹⁷¹⁸Clinical Trials Regulations 2004, amended from 28 April 2026¹⁹
US retention5 years after submission, or 2 years after a marketing approval if sooner (not for IND or IDE studies); 2 years after the study if never submitted¹1 year after the batch’s expiry date⁴2 years after approval, or after the investigation stops and FDA is told⁶
EU and UK retentionThe period the authorities set¹²²⁰1 year after expiry or 5 years after QP certification, whichever is longer; the same in Great Britain¹³¹⁷²¹Trial master file: 25 years after the trial ends; in the UK, for trials applied for from 28 April 2026⁹²²

2Which practice applies to this work?

Table 2. “Not GLP” means outside Part 58, not outside your quality system.
WorkPracticeWhy
Tox study for an INDGLPA nonclinical safety study; the investigational new drug application (IND) states it met Part 58, or why not¹⁶
Safety pharmacology coreGLP, ordinarilyICH S7A: the core battery “should ordinarily be conducted in compliance with GLP”²³
Efficacy or screeningNot GLPPart 58 excludes exploratory studies; primary pharmacodynamic studies need not be GLP¹²³
Dose formulation analysisGLPMixtures are tested for uniformity and concentration¹
Test article stabilityGLPDetermined by the testing facility or the sponsor, before or during the study (58.105(b))¹
Tox batch testingGLP, for FDASponsor or facility may characterise it, under GLP. OECD also allows a supplier; the report says who did it and may name the quality system²⁴²⁵²⁶
Tox batch manufactureGMP not requiredPart 58 asks for characterisation and documented synthesis, and does not mention GMP¹
Assay developmentNot GLPThe GLPs do not apply to developing methods or setting specifications²⁴
Toxicokinetic samplesGLPICH M10: bioanalysis of a GLP study’s toxicokinetic (TK) samples should conform to GLP²⁷
Phase 1 batch (US)Statutory CGMPExempt from Part 211 until used in phase 2 or 3 or marketed²²⁸
Trial batch (EU)GMPArticle 63 requires GMP at every phase, except hospital processes under Article 61(5)⁹²⁹
Trial batch (GB)GMPGreat Britain applies Directive 2003/94/EC, not Regulation 2017/1569; MHRA’s IMP guidelines, still to be published, will reflect the 2010 Annex 13³⁰
GMP method validationGMPAccuracy, sensitivity, specificity and reproducibility established and documented (211.165(e))⁴
Clinical sample analysisGCPFDA inspects bioavailability and bioequivalence (BA/BE) bioanalysis under CP 7348.004; EMA’s GCP inspectors set expectations³¹³²
Bioequivalence studyGCPParts 50 and 56 always; Part 312 when run under an IND, which 320.31 requires for some³³
Device biocompatibilityGLPPart 58 names IDEs and PMAs; FDA’s ISO 10993-1 guidance asks 510(k)s too for a GLP statement or reasons¹³⁴
Device trial (US)GCPAn investigational device exemption (IDE) under Part 812, with Parts 50 and 56³⁵
Trial device build (US)Design controls onlyAn IDE exempts the device from GMP except design and development, 820.10(c), where that applies³⁵³⁶

2.1The judgement calls behind the table.

  • GLP material need not be GMP material, but it qualifies your impurities. Under ICH Q3A(R2), an impurity is qualified at the level present in material “adequately tested in safety and/or clinical studies”, so a tox batch purer than later batches qualifies less. At registration, a higher level above the qualification threshold (0.15% or 1.0 mg a day, whichever is lower, up to a maximum daily dose of 2 g) calls for a justification, more safety data or a lower limit.³⁷ For DNA-reactive impurities, ICH M7’s 1.5 µg a day protects for a lifetime of daily exposure, and treatment for up to a month allows 120 µg a day.³⁸
  • Not every bioequivalence study needs an IND. One is needed for a new chemical entity, a radiolabelled or cytotoxic product, doses beyond the label, or a multiple-dose study of an extended-release product with no completed single-dose study. Exempt studies still report serious adverse events to FDA.³³

3Checklist: one laboratory running GLP studies and GMP testing.

A contract laboratory can run both, but each study or batch follows the rule for its purpose, under that rule’s quality unit.¹⁴

Table 3. Section numbers are from 21 CFR Parts 58 and 211 and OECD No. 17.¹⁴³⁹⁴⁰⁴¹⁵
CheckGLP study (Part 58)GMP testing (Part 211)
Independent unitQA unit “entirely separate from” the study’s staff (58.35(a))Quality control unit that approves or rejects (211.22(a))
Work instructionApproved protocol for each study (58.120)Specifications and test procedures the quality control unit approved (211.160(a))
TrackingQA’s master schedule of every study (58.35(b)(1))Each batch’s records reviewed before release (211.192)
DeviationsAuthorised by the study director, documented in raw data (58.81(a))Recorded and justified (211.160(a)); failures investigated (211.192)
InstrumentsTested, calibrated or standardised under SOPs (58.63)Calibrated under a written programme; failing ones not used (211.160(b)(4))
Computer systemsInventoried, validated, audit-trailed (OECD No. 17, 1.5, 2.1, 3.4); Part 11 in the USChanges by authorised staff, input and output checked, backups kept (211.68(b)); Part 11; EU Annex 11
ArchiveIndexed, with a named archivist and authorised entry only (58.190)Available at the site for inspection (211.180(c))
Sign-offQA statement with the final report (58.35(b)(7))Batch approved or rejected (211.22(a)); in the EU, QP certification

4How each is inspected and certified.

  • GLP. FDA inspects under Compliance Program 7348.808, implemented on 6 October 2026, and its investigators ask who validated each computerised system.²⁵ Part 58 has no certificate; serious failure can lead to disqualification.¹ In the EU, each Member State designates authorities that inspect laboratories claiming GLP and audit their studies, and their results bind the other Member States.¹¹ The MHRA issues a “statement of GLP compliance”, and OECD members accept each other’s data from studies run to OECD Test Guidelines and GLP.¹⁶⁴²
  • GMP. FDA’s preapproval inspections for new and generic drug applications (NDAs and ANDAs) follow Compliance Program 7346.832, revised from 10 August 2026: commercial readiness, conformance to the application, data integrity and commitment to quality in development.⁴³ Device makers have been inspected under Compliance Program 7382.850 since QSIT ended on 2 February 2026, the day the QMSR took effect.⁴⁴³⁶ EU sites are inspected by national authorities; see what a GMP certificate is.¹³
  • GCP. FDA inspects clinical investigators under Compliance Program 7348.811, sponsors and CROs under 7348.810, and BA/BE studies under 7348.003 and 7348.004.⁴⁵⁴⁶ EU Member States appoint inspectors under Article 78 of the Clinical Trials Regulation.⁹

Two 2026 warning letters show what these inspections catch. At a GLP testing facility:

“…the testing facility failed to test, by appropriate analytical methods, the resulting mixtures to determine their uniformity and concentration before dosing all animals in studies (b)(4) and (b)(4).” HealthPartners Neuroscience Center Research and Innovation, warning letter, 19 May 2026⁴⁷

At Alembic, in a bioequivalence study under an IND, FDA faulted the consent form:

“…stating that ‘no part of it is of an experimental nature’ created inconsistencies within the ICF, and these inconsistencies may lead individuals to mistaken conclusions about the type of study and its purpose.” Pratik Doshi, M.D., Alembic Pharmaceuticals Ltd., warning letter, 10 July 2026⁴⁸

5What has changed, and what is still proposed.

  • GCP. ICH adopted E6(R3) on 6 January 2025; its principles and Annex 1 took effect in the EU on 23 July 2025 and became final FDA guidance in September 2025. Annex 2, on pragmatic, decentralised and real-world-data trials, was adopted by ICH on 3 June 2026 and takes effect in the EU on 15 January 2027; FDA has only its December 2024 draft.³¹⁵¹⁰⁴⁹
  • FDA wording. A direct final rule of 22 September 2026, with a companion proposal, replaces “animal” with “nonclinical” studies in certain sections, including the IND’s pharmacology and toxicology section, from 4 February 2027 unless significant adverse comments arrive by 7 December 2026. Part 58 is “outside the scope of this rule”.⁵⁰⁵¹
  • GLP, still proposed. FDA proposed a “GLP Quality System” for Part 58 in August 2016. Its 2026 regulatory agenda set August 2026 for a new proposal that would “simultaneously withdraw the 2016 proposed rule”. That date passed with nothing in the Federal Register by 8 November 2026.⁵²⁵³⁵⁴

6How it runs in Seal.

Seal configures workflows for GMP, GLP, GCP, GDP and GPvP operations to the regulations and jurisdictions that apply to your products, alongside the rest of the quality system. In the QC laboratory, samples enter one controlled intake with their requirements attached, instrument data keeps its source, and results are checked against the applicable specification version before the approved decision returns to the batch.

For clinical operations, trial data, safety records and documents can stay in their existing systems and are connected through scoped connections or exports, and Neil can prepare a review brief with source references and evidence gaps for the study team to verify. Every record keeps its audit history and electronic signatures, with controls to support 21 CFR Part 11 and EU GMP Annex 11, as set out under Regulatory and validation.

References

  1. 121 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies, sections 58.1, 58.3, 58.33, 58.35, 58.63, 58.81, 58.105, 58.113, 58.120, 58.190, 58.195 and 58.200 to 58.219, eCFR, current to 5 November 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 (read 8 November 2026)
  2. 221 CFR Part 210, sections 210.1 and 210.2, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210 (read 7 November 2026)
  3. 3ICH E6(R3) Guideline for Good Clinical Practice, ICH, adopted 6 January 2025, introduction. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf (read 7 November 2026)
  4. 421 CFR Part 211, sections 211.22, 211.68, 211.160, 211.165, 211.180, 211.188 and 211.192, Current Good Manufacturing Practice for Finished Pharmaceuticals, eCFR, current to 5 November 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211 (read 8 November 2026)
  5. 5Directive 2001/83/EC on the Community code relating to medicinal products for human use, Article 51, EUR-Lex, consolidated text of 1 January 2025. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02001L0083-20250101 (read 7 November 2026)
  6. 621 CFR Part 312, sections 312.23(a)(8), 312.50, 312.60 and 312.62, Investigational New Drug Application, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312 (read 7 November 2026)
  7. 721 CFR 56.103, Circumstances in which IRB review is required, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-56/subpart-A/section-56.103 (read 7 November 2026)
  8. 821 CFR 50.20, General requirements for informed consent, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-50/subpart-B/section-50.20 (read 7 November 2026)
  9. 9Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, Articles 47, 58, 61, 62, 63, 64 and 78, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32014R0536 (read 8 November 2026)
  10. 10E6(R3) Good Clinical Practice, final guidance for industry, contains nonbinding recommendations, FDA, September 2025. https://www.fda.gov/media/169090/download (read 8 November 2026)
  11. 11Directive 2004/9/EC on the inspection and verification of good laboratory practice, Articles 1 to 5, EUR-Lex, 11 February 2004. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32004L0009 (read 8 November 2026)
  12. 12Directive 2004/10/EC on the application of the principles of good laboratory practice, Annex I, section II.10.1, EUR-Lex, 11 February 2004. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32004L0010 (read 8 November 2026)
  13. 13Commission Directive (EU) 2017/1572 on the principles and guidelines of good manufacturing practice for medicinal products for human use, Articles 1, 3 and 9, EUR-Lex, 15 September 2017. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017L1572 (read 7 November 2026)
  14. 14EudraLex Volume 4, Good Manufacturing Practice guidelines, European Commission, Part I and Annexes 11 and 13. https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en (read 7 November 2026)
  15. 15ICH E6 Good clinical practice, scientific guideline, European Medicines Agency, overview and Annex 2 entries. https://www.ema.europa.eu/en/ich-e6-good-clinical-practice-scientific-guideline (read 8 November 2026)
  16. 16Good laboratory practice (GLP) for safety tests on chemicals, MHRA, GOV.UK, last updated 14 October 2026, including its link to SI 1999/3106, the Good Laboratory Practice Regulations. https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals (read 8 November 2026)
  17. 17The Human Medicines Regulations 2012 (SI 2012/1916), regulation B17(3), Regulations on good manufacturing practice, which keeps the principles of Directive 2003/94/EC in effect in Great Britain, with Schedule 2A’s modifications of Article 9, legislation.gov.uk. https://www.legislation.gov.uk/uksi/2012/1916/regulation/B17 (read 8 November 2026)
  18. 18The Human Medicines Regulations 2012 (SI 2012/1916), regulation C17, Guidelines on good manufacturing practice and good distribution practice, legislation.gov.uk. https://www.legislation.gov.uk/uksi/2012/1916/regulation/C17 (read 8 November 2026)
  19. 19Clinical trials for medicines: Clinical Trials Regulations transitional arrangements, MHRA, last updated 15 July 2026, summary and the transitional arrangements for good clinical practice. https://www.gov.uk/guidance/clinical-trials-for-medicines-clinical-trials-regulations-transitional-arrangements (read 8 November 2026)
  20. 20The Good Laboratory Practice Regulations 1999 (SI 1999/3106), Schedule 1, Part X, paragraph 1(1), legislation.gov.uk. https://www.legislation.gov.uk/uksi/1999/3106/schedule/1 (read 8 November 2026)
  21. 21Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use, Article 9(1), EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32003L0094 (read 8 November 2026)
  22. 22The Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031), regulation 31A(7) and (7A), as amended by SI 2025/538, legislation.gov.uk. https://www.legislation.gov.uk/uksi/2004/1031/regulation/31A (read 8 November 2026)
  23. 23ICH S7A Safety Pharmacology Studies for Human Pharmaceuticals, ICH, Step 4 version of 8 November 2000, section 2.11. https://database.ich.org/sites/default/files/S7A_Guideline.pdf (read 8 November 2026)
  24. 241981 Questions and Answers, Good Laboratory Practice Regulations, FDA, June 1981, with editorial changes to July 2007, sections 58.1, 58.10 and 58.105. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/nonclinical-laboratories-inspected-under-good-laboratory-practices/1981-questions-answers-good-laboratory-practice-regulations (read 8 November 2026)
  25. 25Compliance Program 7348.808, Good Laboratory Practice (Nonclinical Laboratories), FDA, implemented 6 October 2026, Parts II and III. https://www.fda.gov/media/75891/download (read 8 November 2026)
  26. 26Advisory Document of the Working Group on Good Laboratory Practice on the Management, Characterisation and Use of Test Items, OECD Series on Principles of GLP and Compliance Monitoring No. 19, ENV/JM/MONO(2018)6, OECD, 19 April 2018, paragraphs 35, 40 and 41. https://www.oecd.org/content/dam/oecd/en/publications/reports/2018/04/management-characterisation-and-use-of-test-items-used-in-glp-studies_3471a5de/da9ee953-en.pdf (read 8 November 2026)
  27. 27ICH M10 Bioanalytical Method Validation and Study Sample Analysis, ICH, adopted 24 May 2022, section 1.3. https://database.ich.org/sites/default/files/M10_Guideline_Step4_2022_0524.pdf (read 7 November 2026)
  28. 28Guidance for Industry: CGMP for Phase 1 Investigational Drugs, FDA, July 2008, sections V.B and V.F. https://www.fda.gov/media/70975/download (read 7 November 2026)
  29. 29Commission Delegated Regulation (EU) 2017/1569 on good manufacturing practice for investigational medicinal products for human use, Article 1 and recital 3, EUR-Lex. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R1569 (read 7 November 2026)
  30. 30Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products, MHRA, last updated 28 April 2026, section on GMP for investigational medicinal products. https://www.gov.uk/guidance/clinical-trials-for-medicines-good-manufacturing-practice-and-radiopharmaceutical-investigational-medicinal-products (read 8 November 2026)
  31. 31Compliance Program 7348.004, In Vivo Bioavailability/Bioequivalence Studies (Analytical), FDA, implemented 1 May 2018, Part I. https://www.fda.gov/media/112533/download (read 7 November 2026)
  32. 32Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples, EMA/INS/GCP/532137/2010, GCP Inspectors Working Group, European Medicines Agency, 28 February 2012, sections 2 and 3. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-laboratories-perform-analysis-or-evaluation-clinical-trial-samples_en.pdf (read 7 November 2026)
  33. 3321 CFR 320.31, Applicability of requirements regarding an Investigational New Drug Application, paragraphs (a) to (d), eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-320/subpart-C/section-320.31 (read 7 November 2026)
  34. 34Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”, guidance for industry and FDA staff, FDA, 8 September 2023, section IV and footnote 31. https://www.fda.gov/media/142959/download (read 8 November 2026)
  35. 3521 CFR 812.1 and 812.2, Investigational Device Exemptions, scope and applicability, eCFR, current to 5 November 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-812 (read 8 November 2026)
  36. 3621 CFR 820.1 and 820.10, Quality Management System Regulation, eCFR, current to 5 November 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 (read 8 November 2026)
  37. 37ICH Q3A(R2) Impurities in New Drug Substances, ICH, current Step 4 version of 25 October 2006, sections 1 and 7 and Attachment 1. https://database.ich.org/sites/default/files/Q3A%28R2%29%20Guideline.pdf (read 8 November 2026)
  38. 38ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk, ICH, adopted 3 April 2023, sections 1, 7.1 and 7.3, Table 2. https://database.ich.org/sites/default/files/ICH_M7%28R2%29_Guideline_Step4_2023_0216_0.pdf (read 8 November 2026)
  39. 39Application of GLP Principles to Computerised Systems, OECD Series on Principles of GLP and Compliance Monitoring No. 17, ENV/JM/MONO(2016)13, OECD, 9 November 2022, replacing the version of 22 April 2016, sections 1.5, 2.1 and 3.4. https://www.oecd.org/en/publications/2016/04/application-of-glp-principles-to-computerised-systems_7d05366e.html (read 8 November 2026)
  40. 40EudraLex Volume 4, Annex 11: Computerised Systems, revision 1, European Commission, 2011, principle. https://health.ec.europa.eu/document/download/8d305550-dd22-4dad-8463-2ddb4a1345f1_en?filename=annex11_01-2011_en.pdf (read 7 November 2026)
  41. 4121 CFR 11.1, Scope, Electronic Records; Electronic Signatures, eCFR. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11/subpart-A/section-11.1 (read 7 November 2026)
  42. 42Decision of the Council concerning the Mutual Acceptance of Data in the Assessment of Chemicals, OECD/LEGAL/0194, adopted 12 May 1981, amended 6 September 2019, Part I and Annex II. https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0194 (read 7 November 2026)
  43. 43Compliance Program 7346.832, Preapproval Inspections, FDA, issued 29 June 2026, implemented 10 August 2026, Part II. https://www.fda.gov/media/193382/download (read 7 November 2026)
  44. 44Quality Management System Regulation: Frequently Asked Questions, FDA, update of 2 February 2026, introduction and questions 6 and 9. https://www.fda.gov/medical-devices/quality-management-system-regulation-qmsr/quality-management-system-regulation-frequently-asked-questions (read 8 November 2026)
  45. 45Bioresearch Monitoring Program (BIMO) Compliance Programs, FDA, content current as of 15 October 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-program-manual/bioresearch-monitoring-program-bimo-compliance-programs (read 7 November 2026)
  46. 46Compliance Program 7348.811, Clinical Investigators and Sponsor-Investigators, FDA, implemented 22 July 2020, Part I. https://www.fda.gov/media/75927/download (read 7 November 2026)
  47. 47HealthPartners Neuroscience Center Research and Innovation, warning letter, MARCS-CMS 725333, FDA, 19 May 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/healthpartners-neuroscience-center-research-and-innovation-725333-05192026 (read 7 November 2026)
  48. 48Pratik Doshi, M.D., Alembic Pharmaceuticals Ltd., warning letter, MARCS-CMS 731020, FDA, 10 July 2026, footnote 1. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pratik-doshi-md-alembic-pharmaceuticals-ltd-731020-07102026 (read 7 November 2026)
  49. 49E6(R3) Good Clinical Practice: Annex 2, draft guidance for industry, FDA, December 2024, docket FDA-2024-D-5601, page content current as of 30 December 2024. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r3-good-clinical-practice-annex-2 (read 8 November 2026)
  50. 50Nonclinical Testing Terminology, proposed rule, FDA, 91 FR 60036, 22 September 2026, FR Doc. 2026-19349, docket FDA-2026-N-5347, summary, dates, section V.A.6 and footnote 5. https://www.federalregister.gov/documents/2026/09/22/2026-19349/nonclinical-testing-terminology (read 8 November 2026)
  51. 51Nonclinical Testing Terminology, direct final rule, FDA, 91 FR 59988, 22 September 2026, FR Doc. 2026-19350, dates. https://www.federalregister.gov/documents/2026/09/22/2026-19350/nonclinical-testing-terminology (read 8 November 2026)
  52. 52Good Laboratory Practice for Nonclinical Laboratory Studies, proposed rule, FDA, 81 FR 58342, 24 August 2016, docket FDA-2010-N-0548. https://www.federalregister.gov/documents/2016/08/24/2016-19875/good-laboratory-practice-for-nonclinical-laboratory-studies (read 7 November 2026)
  53. 53Good Laboratory Practice for Nonclinical Laboratory Studies, RIN 0910-AJ01, Unified Agenda entry labelled 2026 (publication 202510), abstract and timetable, Office of Information and Regulatory Affairs, Reginfo.gov. https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202510&RIN=0910-AJ01 (read 8 November 2026)

AQuestions and answers

Is ICH E6(R3) legally binding?

Not in itself. FDA issued it in September 2025 as guidance with nonbinding recommendations; the binding US rules for drug trials are 21 CFR Parts 50, 56 and 312. In the EU, the Clinical Trials Regulation requires sponsors and investigators to follow the principles of GCP and take account of the ICH GCP guidelines.

What is good clinical laboratory practice (GCLP)?

Not a separate regulation. The term describes running laboratories that analyse clinical trial samples to GCP standards, borrowing what fits from GLP. The rule that applies is GCP: EMA’s GCP inspectors set out their expectations for these laboratories in a 2012 reflection paper. In the US, a laboratory that reports results about individual participants’ health, such as safety tests, also needs CLIA certification; a research laboratory that reports no patient-specific results is exempt.

Does a GLP lab need Part 11?

Yes, for any GLP record it keeps electronically. Part 11 applies to electronic records created, modified, maintained, archived, retrieved or transmitted under any FDA records requirement, Part 58 included, and to electronic signatures applied to them. Outside the US, OECD GLP document No. 17 sets the expectation: a life-cycle, risk-based validation of each computerised system with a focus on data integrity.

Does a US phase 1 batch need independent release?

FDA recommends it but does not insist. Its 2008 phase 1 guidance asks for quality control independent of manufacturing, especially for the review and release of each batch. In some small operations the same person may make and release a batch, but FDA then strongly recommends that another qualified person periodically reviews the manufacturing records. The EU has no such latitude: a Qualified Person certifies each investigational batch made in or imported into the EU, whatever the phase. The exceptions are authorised medicines used without modification and some preparation or relabelling in hospitals taking part in the trial.

Can a non-GLP tox study support an IND?

It can be submitted. For each nonclinical study subject to Part 58, the IND must state either that it complied or, briefly, why it did not. The pharmacology and toxicology section as a whole must still support the sponsor’s conclusion that the proposed trial is reasonably safe to conduct. Studies outside Part 58, such as exploratory screens, need no compliance statement.

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