QUALITY ASSURANCE CENTRES EQUIPPED WITH GPHF MINILAB KITS FOR SCREENING OF MEDICINES

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.

  1. 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).

  2. Disintegration

    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.

  3. Visual inspection

    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:

    SNQUALITY ASSURANCE CENTER
    LAKE ZONE
    1Geita RRH
    2Bukoba RRH
    3Mtukula
    4Musoma RRH
    5Sirari
    6TMDA – Mwanza
    NORTHERN ZONE
    1Manyara RRH
    2Kilimanjaro RRH
    3KIA
    4Namanga
    5TMDA - Arusha
    EASTERN ZONE
    1Horohoro
    2Bombo RRH
    SOUTHERN ZONE
    1Lindi RRH
    2Mtwara RRH
    3Songea RRH
    SOUTHERN HIGHLAND ZONE
    1Mbeya RRH
    2Tunduma RRH
    3Sumbawanga RRH
    4Iringa RRH
    CENTRAL ZONE
    1TMDA - Dodoma
    WESTERN ZONE
    1Tabora RRH
    2Kigoma RRH
    3Katavi RRH
    TMDA QC LAB - DSM