title: The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience.
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.
authors.affiliation: School of Pharmacy, Muhimbili University of Health and Allied Sciences, P.O. Box 65526, Dar es Salaam, Tanzania. peterrisha@muchs.ac.tz
authors.forename: Peter Gasper
authors.initials: PG
authors.lastname: Risha
authors.forename: Zera
authors.initials: Z
authors.lastname: Msuya
authors.forename: Malcolm
authors.initials: M
authors.lastname: Clark
authors.forename: Keith
authors.initials: K
authors.lastname: Johnson
authors.forename: Margareth
authors.initials: M
authors.lastname: Ndomondo-Sigonda
authors.forename: Thomas
authors.initials: T
authors.lastname: Layloff
mesh_terms: D002855:Chromatography, Thin Layer / Q000295:instrumentation*; D003663:Decision Trees; D004340:Drug Contamination / Q000517:prevention & control; D004345:Drug Industry / Q000592:standards*; D011307:Drug Prescriptions / Q000592:standards*; D033161:Government Regulation; D006295:Health Resources; D006801:Humans; D007322:Instillation, Drug; D038622:Internationality; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D015397:Program Evaluation; D011635:Public Health Administration / Q000379:methods*; D011786:Quality Control; D012985:Software Design; D013636:Tanzania