Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved]
Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competenci...
| Main Authors: | , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wellcome
2018-10-01
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| Series: | Wellcome Open Research |
| Online Access: | https://wellcomeopenresearch.org/articles/3-137/v1 |
| _version_ | 1818950954888724480 |
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| author | Horace Gumba Joseph Waichungo Brett Lowe Alfred Mwanzu Robert Musyimi Johnstone Thitiri Caroline Tigoi Martin Kamui James A. Berkley Ronald Ngetich Susan Kavai Samuel Kariuki |
| author_facet | Horace Gumba Joseph Waichungo Brett Lowe Alfred Mwanzu Robert Musyimi Johnstone Thitiri Caroline Tigoi Martin Kamui James A. Berkley Ronald Ngetich Susan Kavai Samuel Kariuki |
| author_sort | Horace Gumba |
| collection | DOAJ |
| description | Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement. |
| first_indexed | 2024-12-20T09:26:48Z |
| format | Article |
| id | doaj.art-49b9b648674a4991b692d8444364091f |
| institution | Directory Open Access Journal |
| issn | 2398-502X |
| language | English |
| last_indexed | 2024-12-20T09:26:48Z |
| publishDate | 2018-10-01 |
| publisher | Wellcome |
| record_format | Article |
| series | Wellcome Open Research |
| spelling | doaj.art-49b9b648674a4991b692d8444364091f2022-12-21T19:45:10ZengWellcomeWellcome Open Research2398-502X2018-10-01310.12688/wellcomeopenres.14860.116195Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved]Horace Gumba0Joseph Waichungo1Brett Lowe2Alfred Mwanzu3Robert Musyimi4Johnstone Thitiri5Caroline Tigoi6Martin Kamui7James A. Berkley8Ronald Ngetich9Susan Kavai10Samuel Kariuki11KEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaCentre for Tropical Medicine and Global Health, University of Oxford, London, UKKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Wellcome Trust Research Programe, Kilifi, Coast, 80108, KenyaKEMRI-Centre for Microbiology and Research, Nairobi, KenyaKEMRI-Centre for Microbiology and Research, Nairobi, KenyaKEMRI-Centre for Microbiology and Research, Nairobi, KenyaBackground: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of Good Clinical Laboratory Practice (GCLP) at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.https://wellcomeopenresearch.org/articles/3-137/v1 |
| spellingShingle | Horace Gumba Joseph Waichungo Brett Lowe Alfred Mwanzu Robert Musyimi Johnstone Thitiri Caroline Tigoi Martin Kamui James A. Berkley Ronald Ngetich Susan Kavai Samuel Kariuki Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved] Wellcome Open Research |
| title | Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved] |
| title_full | Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved] |
| title_fullStr | Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved] |
| title_full_unstemmed | Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved] |
| title_short | Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research [version 1; referees: 2 approved] |
| title_sort | implementing a quality management system using good clinical laboratory practice guidelines at kemri cmr to support medical research version 1 referees 2 approved |
| url | https://wellcomeopenresearch.org/articles/3-137/v1 |
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