GPHF Minilab kit is a simple and relatively easy and quick technique for quality screening of medicinal products in the field. It contains all necessary requirements for testing more than 100 types of medicinal products. The kit is capable of carrying out visual inspection, disintegration tests for oral solid dosage forms and thin-layer chromatography (TLC) for identification of active pharmaceutical ingredients (APIs) present in a formulation.
Thin-layer chromatography (TLC)
TLC method is a separation technique used for identification of APIs present in the finished product formulation. The method employs the principle of comparing spots obtained between the test and reference solutions in terms of colour intensity, shape, size of the spot together with the distance of the spots travelled from the origin (retardation factor, Rf value).
Simple disintegration testing is used to test the ability of oral solid dosage forms (e.g. tablets, capsules) to break into small particles. The disintegration process assists the product to then dissolve and get into the solution (dissolution process) thus releasing the active ingredient. The test is simply done using a 100 ml wide neck glass bottle filled with water heated to a temperature of 37˚C. Each tablet is shaken occasionally, and they should disintegrate within the required time (15, 30 or 60 minutes) depending on the product and type of formulation.
Visual inspection is one of the most important tests used for the identification of falsified or incorrectly labeled medicines. The received product is compared with the authentic product in respect of drug packaging, labeling information, and units.
TMDA has facilitated 25 minilab kits in 25 different quality assurance centers in the country which are located at ports of entries, regional referral (RRH) hospitals and TMDA zone offices as listed in table below:
SN QUALITY ASSURANCE CENTER LAKE ZONE 1 Geita RRH 2 Bukoba RRH 3 Mtukula 4 Musoma RRH 5 Sirari 6 TMDA – Mwanza NORTHERN ZONE 1 Manyara RRH 2 Kilimanjaro RRH 3 KIA 4 Namanga 5 TMDA - Arusha EASTERN ZONE 1 Horohoro 2 Bombo RRH SOUTHERN ZONE 1 Lindi RRH 2 Mtwara RRH 3 Songea RRH SOUTHERN HIGHLAND ZONE 1 Mbeya RRH 2 Tunduma RRH 3 Sumbawanga RRH 4 Iringa RRH CENTRAL ZONE 1 TMDA - Dodoma WESTERN ZONE 1 Tabora RRH 2 Kigoma RRH 3 Katavi RRH TMDA QC LAB - DSM