The use of Minilabs® to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience

Peter Gasper Risha, Zera Msuya, Malcolm Clark, Keith Johnson, Margareth Ndomondo-Sigonda and Thomas Layloff

Health Policy, 2008, vol. 87, issue 2, 217-222

Abstract: The Tanzania Food and Drugs Authority piloted the use of Minilab® kits, a thin-layer-chromatographic based drug quality testing technique, in a two-tier quality assurance program. The program is intended to improve testing capacity with timely screening of the quality of medicines as they enter the market. After 1 week training of inspectors on Minilab® screening techniques, they were stationed at key Ports-of-Entry (POE) to screen the quality of imported medicines. In addition, three non-Ports-of-Entry centres were established to screen samples collected during Post-Marketing-Surveillance. Standard operating procedures (SOPs) were developed to structure and standardize the implementation process. Over 1200 samples were tested using the Minilab® outside the central quality control laboratory (QCL), almost doubling the previous testing capacity. The program contributed to increased regulatory reach and visibility of the Authority throughout the country, serving as a deterrent against entry of substandard medicines into market. The use of Minilab® for quality screening was inexpensive and provided a high sample throughput. However, it suffers from the limitation that it can reliably detect only grossly substandard or wrong drug samples and therefore, it should not be used as an independent testing resource but in conjunction with a full-service quality control laboratory capable of auditing reported substandard results.

Date: 2008
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://www.sciencedirect.com/science/article/pii/S0168-8510(08)00006-7
Full text for ScienceDirect subscribers only

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:eee:hepoli:v:87:y:2008:i:2:p:217-222

Access Statistics for this article

Health Policy is currently edited by Katrien Kesteloot, Mia Defever and Irina Cleemput

More articles in Health Policy from Elsevier
Bibliographic data for series maintained by Catherine Liu () and ().