Laboratory accreditation can help ensure the quality of analytical reports generated by such testing facilities. ![]() Institutions that conduct medicines testing apply international standards to improve the processes in their Quality Control laboratories. Overall, ISO/IEC 17025 accreditation of the NMRA Quality Control laboratory resulted in improved reliability of test reports and enhancement of the laboratory quality system. ConclusionsĪ higher level of quality compliance was exhibited for the laboratory during the post-accreditation years. A reduction in the number of major observations and a decrease in the severity of nonconformities was also observed. Further examination of audits from the years 2013 through 2018 audits also revealed a reduction in the number of nonconformities (χ 2 = 53, p-value = 9.99e-05, r = 0.62). Statistical analysis of the pre- to post- accreditation audits from the years 2013 through 2017 revealed a significant decrease in the total number of nonconformities (χ 2 = 74, p-value = 9.99e-05, r = 0.67). The following research questions were addressed: “does accreditation impact the adherence to quality standards?” and “does accreditation decrease the severity of nonconformities in Quality Control laboratory audits?” Results Pre- and post- accreditation audits of nonconformities for management and technical requirements of the ISO/IEC17025:2005 standards were evaluated from a Quality Control laboratory in the National Agency for Food and Drug Administration and Control (NAFDAC), located in Nigeria, West Africa. This study investigated the impact of ISO/IEC 17025 accreditation on the performance of an NMRA Quality Control laboratory to provide evidence of improved quality compliance within a low-resource setting. Sharing the benefits of laboratory accreditation could help more countries within sub-Saharan Africa overcome existing challenges to achieve accreditation and robust quality systems. Although countries desire to have reliable medicine testing facilities, accrediting a national laboratory to international standards poses financial and technical challenges for many low-income countries. ![]() The National Medicines Regulatory Authority (NMRA) Quality Control laboratories assess the quality of medicines used by the populace as part of their regulatory function. Quality standards are established and maintained to ensure the reliability of laboratory test reports. The number and severity of nonconformities generated during an audit of a medicine testing laboratory indicates its level of quality compliance.
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