PMID- 33228675
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 1472-6963 (Electronic)
IS  - 1472-6963 (Linking)
VI  - 20
IP  - 1
DP  - 2020 Nov 23
TI  - Impact of ISO/IEC 17025 laboratory accreditation in sub-Saharan Africa: a case 
      study.
PG  - 1065
LID - 10.1186/s12913-020-05934-8 [doi]
LID - 1065
AB  - BACKGROUND: 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. METHODS: 
      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?" RESULTS: 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 
      (chi(2) = 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 (chi(2) = 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. CONCLUSIONS: 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.
FAU - Okezue, Mercy A
AU  - Okezue MA
AUID- ORCID: 0000-0002-3157-5021
AD  - School of Agricultural & Biological Engineering, Biotechnology Innovation & 
      Regulatory Science, Purdue University, West Lafayette, USA. mokezue@purdue.edu.
AD  - Bindley Bioscience Centre, Purdue University, 1203 W State St, West Lafayette, 
      IN, 47907, USA. mokezue@purdue.edu.
FAU - Adeyeye, Mojisola C
AU  - Adeyeye MC
AD  - National Agency for Food and Drug Adm. & Control, NAFDAC, Abuja, Nigeria.
FAU - Byrn, Steve J
AU  - Byrn SJ
AD  - Department of Industrial & Physical Pharmacy, Purdue University, West Lafayette, 
      USA.
FAU - Abiola, Victor O
AU  - Abiola VO
AD  - National Agency for Food and Drug Adm. & Control, NAFDAC, Abuja, Nigeria.
FAU - Clase, Kari L
AU  - Clase KL
AD  - School of Agricultural & Biological Engineering, Biotechnology Innovation & 
      Regulatory Science, Purdue University, West Lafayette, USA.
LA  - eng
PT  - Journal Article
DEP - 20201123
PL  - England
TA  - BMC Health Serv Res
JT  - BMC health services research
JID - 101088677
SB  - IM
MH  - *Accreditation
MH  - Africa South of the Sahara
MH  - Africa, Western
MH  - Humans
MH  - *Laboratories
MH  - Nigeria
MH  - Reproducibility of Results
PMC - PMC7686690
OTO - NOTNLM
OT  - Accreditation
OT  - Audits
OT  - ISO/IEC17025: 2005
OT  - Nonconformities
OT  - Quality control laboratory
OT  - Sub-Saharan Africa
COIS- 1st Author worked as a regulatory officer at NAFDAC laboratory for 15 years and 
      is currently a PhD student at Purdue University. 2nd and 5th authors are 
      Management personnel at NAFDAC, Nigeria. 3rd and 4th Authors are Professors, 
      academic advisors to 1st author in her PhD program. The authors declare that they 
      have no conflict of interest.
EDAT- 2020/11/25 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/11/23
CRDT- 2020/11/24 05:38
PHST- 2020/06/09 00:00 [received]
PHST- 2020/11/17 00:00 [accepted]
PHST- 2020/11/24 05:38 [entrez]
PHST- 2020/11/25 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/11/23 00:00 [pmc-release]
AID - 10.1186/s12913-020-05934-8 [pii]
AID - 5934 [pii]
AID - 10.1186/s12913-020-05934-8 [doi]
PST - epublish
SO  - BMC Health Serv Res. 2020 Nov 23;20(1):1065. doi: 10.1186/s12913-020-05934-8.