KEMRI Hosts Africa CDC’s First ISO 20387:2018 Auditor Training Mock Audit, Advancing Biobank Accreditation Efforts

BY LISPER MOKAYA AND ISAAC MUTHOTHO

Inside KEMRI’s Biobank, the future of African biomedical research is being safeguarded one sample at a time. As part of its push for world-class quality, the Institute recently held a mock internal audit seen as a milestone anchored in Africa CDC’s first-ever ISO 20387:2018 Auditor Training hosted in Nairobi.

This exercise presented an invaluable opportunity for KEMRI’s Sample Management and Repository Facility (SMRF) to benchmark its processes against international biobanking standards while identifying priority areas for continuous improvement as the Institute advances toward full ISO 20387:2018 accreditation.

The mock audit formed a practical cornerstone of the week-long training organized by Africa CDC, bringing together 13 biobank professionals from across the African Biobanking Network who previously completed the foundational ISO 20387:2018 course. The Nairobi auditor certification training is designed to build a skilled cadre of professionals capable of conducting internal and external audits within the continent.

The training and audit visit to KEMRI were led by Dr. Ousmane Noel, Chairperson of the Africa CDC Biobanking Network, while Ms. Rose Akide from Uganda Virus Research Institute (UVRI) served as the Lead Auditor. The audit activities included structured interviews with staff, facility observations, and extensive document reviews aligned to ISO 20387:2018 requirements.

Representing the Acting Deputy Director, Lab Services, Biosafety and Biosecurity, Dr. Julian Makau, Mr. Nicholas Mwikwabe received the team and appreciated the budding partnership. “This mock audit has provided us with a clear picture of where we are and what we must strengthen as we pursue ISO 20387:2018 accreditation,” said Mr. Mwikwabe Nicholas. “It also underscores KEMRI’s commitment to ensuring the highest standards in biospecimen management to support world-class health research.”

 Africa CDC emphasized the significance of the training in accelerating the continent’s capacity for quality-assured research infrastructure. “Africa is rapidly expanding its scientific and biobanking capabilities, but quality must grow in equal measure,” noted Dr. Ousmane Noel. “By empowering African biobankers as certified auditors, we are reinforcing a sustainable system of quality assurance that is homegrown, scalable, and globally recognized.”

KEMRI was also proudly represented among the trainees, including Ms. Milkah Mwangi, a KEMRI scientist and the head of Sample management and Biobanking, who completed both phases of the ISO 20387 : 2018 training.

“Being part of this programme has boosted my ability to contribute to KEMRI’s journey toward accreditation,” said Ms. Milkah. “The knowledge and hands-on audit experience gained this week will help us enhance biospecimen integrity and build greater confidence among our researchers and collaborators.”

Lead Auditor, Ms. Rose Akide, highlighted the exemplary collaboration and readiness demonstrated by the KEMRI team. “This exercise demonstrated strong commitment from SMRF. With continued refinement of quality systems, KEMRI Biobank is well-positioned to meet accreditation requirements,” she remarked.

The successful completion of this training marks a pivotal achievement for Africa CDC, solidifying efforts to implement robust Biobank Quality Management Systems (BQMS) across the continent. Certified auditors will now act as central quality champions within the Africa Biobanking network, offering expertise to drive compliance and strengthen regional scientific interoperability.

For KEMRI, the insights gained not only reinforce its leadership in biomedical research but also accelerate preparations to attain internationally recognized accreditation ensuring that every biospecimen stored preserves unmatched scientific value, integrity, and traceability.

Also present during the exercise were Deputy Director Quality Assurance and Risk Management Mr. Patrick Mutinda, and members from the Department of Laboratory Services, Biosafety and Biosecurity, Mr. Cornelius Kipchirchir and Ms. Lucy Mutegi.