vedomostiregmedРегуляторные исследования и экспертиза лекарственных средствRegulatory Research and Medicine Evaluation3034-30623034-3453Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/1991-2919-2024-645vedomostiregmed-645Research ArticleКЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯCLINICAL STUDIESОрганизация деятельности биоаналитических лабораторий согласно принципам надлежащей клинической лабораторной практики (обзор)Organisation of the Work of Bioanalytical Laboratories according to the Principles of Good Clinical Laboratory Practice (Review)https://orcid.org/0000-0002-0152-9841ГибаИ. С.GibaI. S.

Гиба Иван Сергеевич - канд. физ.-мат. наук.

Олимпийский пр., д. 1, Краснодарский край, федеральная территория «Сириус», пгт. Сириус, 354340

Ivan S. Giba - Cand. Sci. (Phys. and Math.).

1 Olympic Ave, Krasnodar Region, Sirius Federal Territory 354340

giba.is@talantiuspeh.ruНаучно-технологический университет «Сириус»РоссияSirius University of Science and TechnologyRussian Federation202429082024145601611Copyright © Гиба И.С., 20242024Гиба И.С.Giba I.S.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.vedomostincesmp.ru/jour/article/view/645ВВЕДЕНИЕ

ВВЕДЕНИЕ. Биоаналитические лаборатории в Российской Федерации должны одновременно соответствовать как требованиям надлежащей лабораторной практики (GLP) для проведения доклинических исследований, так и требованиям надлежащей клинической практики (GCP) для анализа образцов клинических исследований. Для работы подобных лабораторий необходимо создание отдельной ниши GxP практик — принципов надлежащей клинической лабораторной практики (GCLP). Однако данная область регулирования на территории Российской Федерации и стран Евразийского экономического союза (ЕАЭС) на данный момент не сформирована.

ЦЕЛЬ

ЦЕЛЬ. Сравнительный анализ существующего положения в области регулирования деятельности биоаналитических лабораторий на территории Российской Федерации и стран ЕАЭС с международными принципами надлежащей клинической лабораторной практики для формирования общих требований к работе отечественных лабораторий.

ОБСУЖДЕНИЕ

ОБСУЖДЕНИЕ. Проанализированы текущее положение в области регулирования деятельности биоаналитических лабораторий, нормативные документы ЕАЭС по разработке и валидации аналитических методик, а также международные принципы GCLP, включающие кадровую политику лабораторий, порядок документирования процессов, разработку стандартных операционных процедур, валидацию методик, управление биологическими и стандартными образцами. Рассмотрены основные виды деятельности биоаналитических лабораторий и предложены инструменты управления ими, соответствующие международным принципам и требованиям ЕАЭС. Отмечено, что мировая практика применения принципов GCLP достаточно хорошо описана в научной литературе, и этот опыт может быть полезен для применения в работе отечественных лабораторий.

ВЫВОДЫ

ВЫВОДЫ. Внедрение принципов GCLP в деятельность биоаналитических лабораторий в странах ЕАЭС приведет к повышению конкурентоспособности лаборатории на рынке биоаналитических услуг и снижению риска получения недостоверных данных.

INTRODUCTION

INTRODUCTION. Bioanalytical laboratories in the Russian Federation should follow the requirements of both the Good Laboratory Practices (GLP), when performing tests for non-clinical studies, and the Good Clinical Practices (GCP), when analysing samples from clinical studies. The work of such laboratories requires a separate GxP system, the Good Clinical Laboratory Practices (GCLP). However, the GCLP system has not yet been created in the Russian Federation and the Eurasian Economic Union (EAEU).

АIM

АIM. This study aimed to compare the current Russian and EAEU principles regulating the work of bioanalytical laboratories with the international GCLP principles and formulate general requirements for national laboratories.

DISCUSSION

DISCUSSION. The author analysed the current regulation of the work of bioanalytical laboratories, as well as the EAEU regulatory standards for the development and validation of analytical procedures. In addition, the study covered the international GCLP principles that govern the management of human resources, process record keeping, the development of standard operating procedures, the validation of analytical procedures, and the management of biological samples and reference standards in a laboratory. The author considered the key functions of a bioanalytical laboratory and suggested tools to manage them in compliance with the international GCLP principles and the EAEU requirements. It should be noted that scientific publications describe the international practice of applying the GCLP principles fairly well, and the experience of its implementation could be of use to Russian laboratories.

CONCLUSION

CONCLUSION. A bioanalytical laboratory that implements the GCLP principles will increase its competitiveness in the EAEU market for bioanalytical testing services and mitigate its risks of obtaining invalid data.

GCLPбиоаналитикаисследования биоэквивалентностиэффективность и безопасностьдоклинические исследованияклинические исследованияразработка и валидация аналитических методиксистема менеджмента качествабиоаналитические лабораториитребования GLPтребования GCPGCLPGood Clinical Laboratory Practicesbioanalysisbioequivalence studyefficacy and safetynon-clinical studiesclinical trialsdevelopment of analytical proceduresvalidation of analytical proceduresquality management systembioanalytical laboratoriesGLP requirementsGood Laboratory PracticesGCP requirementsGood Clinical PracticesАвтор выражает признательность и благодарность К.Ю. Семенову за участие в обсуждении рукописи.The author would like to extend his gratitude and acknowledgements to Konstantin Yu. Semenov for participating in manuscript discussion.ReferencesГиба ИС, Салиева КР, Батуева АА, Григорьева ИВ, Драй РВ. Внедрение и оценка системы менеджмента качества в области фармацевтической разработки биотехнологических лекарственных препаратов. Ведомости Научного центра экспертизы средств медицинского применения. Регуляторные исследования и экспертиза лекарственных средств. 2024;14(1):62–71. https://doi.org/10.30895/1991-2919-2023-549Giba IS, Salieva KR, Batueva AA, Grigorieva IV, Drai RV. Quality management in pharmaceutical development of biotechnology-derived medicinal products: implementation and evaluation. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Regulatory Research and Medicine Evaluation. 2024;14(1):62–71 (In Russ.). https://doi.org/10.30895/1991-2919-2023-549Рогов ЕС, Белоусов ДЮ, Зырянов СК, Колбин АС, Карпенко ЛИ. Инспекция соблюдения правил Надлежащей клинической практики Росздравнадзором. Качественная клиническая практика. 2018;(1):66–76. https://doi.org/10.24411/2588-0519-2018-10039Rogov ES, Belousov DYu, Zyryanov SK, Kolbin AS, Karpenko LI. GCP inspection by Roszdravnadzor. Good Clinical Practice. 2018;(1):66–76 (In Russ.). https://doi.org/10.24411/2588-0519-2018-10039Трапкова АА. Проведение фармацевтических инспекций на соответствие требованиям GCP ЕАЭС в Российской Федерации является осознанной необходимостью. Безопасность и риск фармакотерапии. 2023;11(2):127–30. https://doi.org/10.30895/2312-7821-2023-11-2-127-130Trapkova AA. Conducting pharmaceutical inspections in the Russian Federation to ensure compliance with the EAEU GCP requirements is an accepted necessity. Safety and Risk of Pharmacotherapy. 2023;11(2):127–30 (In Russ.). https://doi.org/10.30895/2312-7821-2023-11-2-127-130Stevens W. Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur. 2003;10(2):83–9. https://doi.org/10.1080/10529410390262727Stevens W. Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur. 2003;10(2):83–9. https://doi.org/10.1080/10529410390262727Klausner RD, Fauci AS, Corey L, Nabel GJ, Gayle H, Berkley S, et al. Medicine. The need for a global HIV vaccine enterprise. Science. 2003;300(5628):2036–9. https://doi.org/10.1126/science.1086916Klausner RD, Fauci AS, Corey L, Nabel GJ, Gayle H, Berkley S, et al. Medicine. The need for a global HIV vaccine enterprise. Science. 2003;300(5628):2036–9. https://doi.org/10.1126/science.1086916Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, Hitchcock R, et al. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J Pharm Biomed Anal. 2008;46(1):18–29. https://doi.org/10.1016/j.jpba.2007.10.010Ezzelle J, Rodriguez-Chavez IR, Darden JM, Stirewalt M, Kunwar N, Hitchcock R, et al. Guidelines on good clinical laboratory practice: bridging operations between research and clinical research laboratories. J Pharm Biomed Anal. 2008;46(1):18–29. https://doi.org/10.1016/j.jpba.2007.10.010Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. Evaluation and recommendations on Good Clinical Laboratory Practice guidelines for phase I–III clinical trials. PLoS Medicine. 2009;6(5):e1000067. https://doi.org/10.1371/journal.pmed.1000067Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. Evaluation and recommendations on Good Clinical Laboratory Practice guidelines for phase I–III clinical trials. PLoS Medicine. 2009;6(5):e1000067. https://doi.org/10.1371/journal.pmed.1000067Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. P15-05. Evaluation and recommendations on good clinical laboratory practice (GCLP) guidelines for phase I–III HIV vaccine clinical trials. Retrovirology. 2009;6(3):P206. https://doi.org/10.1186/1742-4690-6-S3-P206Sarzotti-Kelsoe M, Cox J, Cleland N, Denny T, Hural J, Needham L, et al. P15-05. Evaluation and recommendations on good clinical laboratory practice (GCLP) guidelines for phase I–III HIV vaccine clinical trials. Retrovirology. 2009;6(3):P206. https://doi.org/10.1186/1742-4690-6-S3-P206Banoo S, Bell D, Bossuyt P, Herring A, Mabey D, Poole F. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol. 2006;4(9):S21–S31. https://doi.org/10.1038/nrmicro1523Banoo S, Bell D, Bossuyt P, Herring A, Mabey D, Poole F. Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol. 2006;4(9):S21–S31. https://doi.org/10.1038/nrmicro1523Roy CK. Good Clinical Laboratory Practice (GCLP): quality demanding from clinical laboratories. Bangladesh J Med Microbiol. 2010;4(1):1–5. https://doi.org/10.3329/bjmm.v4i1.8460Roy CK. Good Clinical Laboratory Practice (GCLP): quality demanding from clinical laboratories. Bangladesh J Med Microbiol. 2010;4(1):1–5. https://doi.org/10.3329/bjmm.v4i1.8460Joshi RK, Sarangi SC, Mohapatra S, Mallick S, Datta SK. A comparative review of ICMR, WHO, and EMA guidelines for good clinical laboratory practices. J Lab Physicians. 2023;15(2):179–86. https://doi.org/10.1055/s-0042-1757237Joshi RK, Sarangi SC, Mohapatra S, Mallick S, Datta SK. A comparative review of ICMR, WHO, and EMA guidelines for good clinical laboratory practices. J Lab Physicians. 2023;15(2):179–86. https://doi.org/10.1055/s-0042-1757237Viana RV, Wallis CL. Good Clinical Laboratory Practice (GCLP) for molecular based tests used in diagnostic laboratories. In: Akyar I. Wide spectra of Quality Control. InTech; 2011. https://doi.org/10.5772/23963Viana RV, Wallis CL. Good Clinical Laboratory Practice (GCLP) for molecular based tests used in diagnostic laboratories. In: Akyar I. Wide spectra of Quality Control. InTech; 2011. https://doi.org/10.5772/23963Gumba H, Musyoki J, Mosobo M, Lowe B. Implementation of Good Clinical Laboratory Practice in an immunology basic research laboratory. Am J Clin Pathol. 2019;151(3):270–4. https://doi.org/10.1093/ajcp/aqy138Gumba H, Musyoki J, Mosobo M, Lowe B. Implementation of Good Clinical Laboratory Practice in an immunology basic research laboratory. Am J Clin Pathol. 2019;151(3):270–4. https://doi.org/10.1093/ajcp/aqy138Patel S, Garima G, Bhatia S, Latha TK, Thakur N, Pujani M, Sharma SB. Effect of Good Clinical Laboratory Practices quality training on knowledge, attitude and practice among laboratory professionals — quasi experimental study. J Clin Diagn Res. 2023;17(9):BC05–BC09. https://doi.org/10.7860/JCDR/2023/62492.18453Patel S, Garima G, Bhatia S, Latha TK, Thakur N, Pujani M, Sharma SB. Effect of Good Clinical Laboratory Practices quality training on knowledge, attitude and practice among laboratory professionals — quasi experimental study. J Clin Diagn Res. 2023;17(9):BC05–BC09. https://doi.org/10.7860/JCDR/2023/62492.18453Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2014;409:91–8. https://doi.org/10.1016/j.jim.2013.09.012Todd CA, Sanchez AM, Garcia A, Denny TN, Sarzotti-Kelsoe M. Implementation of Good Clinical Laboratory Practice (GCLP) guidelines within the External Quality Assurance Program Oversight Laboratory (EQAPOL). J Immunol Methods. 2014;409:91–8. https://doi.org/10.1016/j.jim.2013.09.012Tzankov A, Tornillo L. Hands-on experience: accreditation of pathology laboratories according to ISO 15189. Patho­ biology. 2017;84(3):121–9. https://doi.org/10.1159/000449254Tzankov A, Tornillo L. Hands-on experience: accreditation of pathology laboratories according to ISO 15189. Patho­ biology. 2017;84(3):121–9. https://doi.org/10.1159/000449254Zneimer SM. Guidelines for Good Clinical Laboratory Practice. In: Zneimer SM. Cytogenetic laboratory management: chromosomal, FISH and microarray­based best practices and procedures. John Wiley & Sons, Inc.; 2016. P. 1–70. https://doi.org/10.1002/9781119069782.ch1Zneimer SM. Guidelines for Good Clinical Laboratory Practice. In: Zneimer SM. Cytogenetic laboratory management: chromosomal, FISH and microarray­based best practices and procedures. John Wiley & Sons, Inc.; 2016. P. 1–70. https://doi.org/10.1002/9781119069782.ch1Gough J, Hamrell M. Standard Operating Procedures (SOPs): Why companies must have them, and why they need them. Ther Innov Regul Sci. 2009;43:69–74. https://doi.org/10.1177/009286150904300112Gough J, Hamrell M. Standard Operating Procedures (SOPs): Why companies must have them, and why they need them. Ther Innov Regul Sci. 2009;43:69–74. https://doi.org/10.1177/009286150904300112Amare G. Reviewing the values of a standard operating procedure. Ethiop J Health Sci. 2012;22(3):205–8. PMID: 23209355Amare G. Reviewing the values of a standard operating procedure. Ethiop J Health Sci. 2012;22(3):205–8. PMID: 23209355Schmidt RH, Pierce PD. The use of Standard Operating Procedures (SOPs). In: Handbook of hygiene control in the food industry. Elsevier Ltd.; 2016. P. 221–3. https://doi.org/10.1016/B978-0-08-100155-4.00016-9Schmidt RH, Pierce PD. The use of Standard Operating Procedures (SOPs). In: Handbook of hygiene control in the food industry. Elsevier Ltd.; 2016. P. 221–3. https://doi.org/10.1016/B978-0-08-100155-4.00016-9Hollmann S, Frohme M, Endrullat C, Kremer A, D’Elia D, Regierer B, Nechyporenko A. Ten simple rules on how to write a standard operating procedure. PLoS Comput Biol. 2020;16(9):e1008095. https://doi.org/10.1371/journal.pcbi.1008095Hollmann S, Frohme M, Endrullat C, Kremer A, D’Elia D, Regierer B, Nechyporenko A. Ten simple rules on how to write a standard operating procedure. PLoS Comput Biol. 2020;16(9):e1008095. https://doi.org/10.1371/journal.pcbi.1008095Killcross M. Develop Standard Operating Procedures (SOPs). In: Chemical and process plant commissioning hand-book. Elsevier Ltd.; 2021. P. 155–64. https://doi.org/10.1016/B978-0-12-824049-6.00007-XKillcross M. Develop Standard Operating Procedures (SOPs). In: Chemical and process plant commissioning hand-book. Elsevier Ltd.; 2021. P. 155–64. https://doi.org/10.1016/B978-0-12-824049-6.00007-X

The authors declare that there are no conflicts of interest present.