School of Agricultural & Biological Engineering, Biotechnology Innovation & Regulatory Science, Purdue University, West Lafayette, USA.
Bindley Bioscience Centre, Purdue University, 1203 W State St, West Lafayette, IN, 47907, USA.
BMC Health Serv Res. 2020 Nov 23;20(1):1065. doi: 10.1186/s12913-020-05934-8.
The number and severity of nonconformities generated during an audit of a medicine testing laboratory indicates its level of quality compliance. Quality standards are established and maintained to ensure the reliability of laboratory test reports. The National Medicines Regulatory Authority (NMRA) Quality Control laboratories assess the quality of medicines used by the populace as part of their regulatory function. 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. Sharing the benefits of laboratory accreditation could help more countries within sub-Saharan Africa overcome existing challenges to achieve accreditation and robust quality systems. 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.
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. 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?"
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 = 74, p-value = 9.99e-05, r = 0.67). Further examination of audits from the years 2013 through 2018 audits also revealed a reduction in the number of nonconformities (χ = 53, p-value = 9.99e-05, r = 0.62). A reduction in the number of major observations and a decrease in the severity of nonconformities was also observed.
A higher level of quality compliance was exhibited for the laboratory during the post-accreditation years. 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.
在对医学检测实验室进行审核时发现的不符合项数量和严重程度表明了其质量合规水平。质量标准的建立和维护是为了确保实验室检测报告的可靠性。国家药品监管管理局（NMRA）的质控实验室作为其监管职能的一部分，评估民众所用药品的质量。尽管各国都希望拥有可靠的药品检测设施，但对许多低收入国家来说，按照国际标准认可国家实验室在财务和技术方面都具有挑战性。在撒哈拉以南非洲地区，分享实验室认可的益处可以帮助更多国家克服现有的障碍，实现认可和健全的质量体系。本研究调查了 ISO/IEC 17025 认可对 NMRA 质控实验室性能的影响，以提供在资源匮乏环境下提高质量合规性的证据。
从位于西非尼日利亚的国家食品药品监督管理局（NAFDAC）的质控实验室评估了 ISO/IEC 17025：2005 标准的管理和技术要求的认可前和认可后不符合项的审核。提出了以下研究问题：“认可是否会影响质量标准的遵守？”和“认可是否会减少质控实验室审核中的不符合项的严重程度？”
对 2013 年至 2017 年的认可前至认可后审核进行的统计分析显示，不符合项总数显著减少（χ=74，p 值=9.99e-05，r=0.67）。进一步分析 2013 年至 2018 年的审核还显示，不符合项数量减少（χ=53，p 值=9.99e-05，r=0.62）。也观察到不符合项的主要观测值数量减少，不符合项的严重程度降低。
在认可后的年份，实验室表现出更高水平的质量合规性。总体而言，NMRA 质控实验室的 ISO/IEC 17025 认可提高了检测报告的可靠性，并增强了实验室质量体系。
