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KAMPALA WORKSHOP ON UN LIFE SAVING COMODITIES

KAMPALA WORKSHOP ON UN LIFE SAVING COMODITIES. September, 2015 Chimpaye Julius. Activities done by TFDA to ensure quality of medicines. Product registration GMP inspection Premise registration and licensing Three approaches are used in the monitoring of

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KAMPALA WORKSHOP ON UN LIFE SAVING COMODITIES

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  1. KAMPALA WORKSHOP ON UN LIFE SAVING COMODITIES September, 2015 Chimpaye Julius

  2. Activities done by TFDA to ensure quality of medicines.

  3. Product registration • GMP inspection • Premise registration and licensing Three approaches are used in the monitoring of quality of medicines in the country :- • Product inspection and testing at POEs • Product inspection within distribution channels • Structured quality surveillance programme

  4. Product inspection and testing at POEs • Physical examination of the product and importation documents before release for market:- • Matching of product’s details with registered product • Labeling • Evidence of tampering of labels • Language • Product descriptions such as size, shape, color, odor etc

  5. Samples required for testing :- Anti retroviral, Anti tuberculosis, Anti malaria , Selected Antibiotic and any other Suspicious product Testing required:- • Screening test • Disintegration (for solid dosage forms) • Color reaction • Thin Layer Chromatograph • Full testing at TFDA Laboratory if sample fail screening test

  6. Product inspection and testing at POEs Testing required:- • Screening test by use of Minilab Kit • Disintegration (for solid dosage forms) • Thin Layer Chromatograph • Screening test by use of Minilab Kit

  7. Product inspection within Distributing Channels • Inspectors may take samples for testing from DLDM, retail pharmacy, wholesaler pharmacy, MSD, Hospitals, Health Centers, Dispensaries or from industries during inspections • Samples may include:- • Products associated with adverse clinical reactions, unexpected illnesses or deaths

  8. Product inspection within Distributing Channels • Unregistered or unauthorized product encountered during inspection is confiscated and legal action is taken • Products that are reported to be ineffective • Suspicious samples or product that shows signs of possible deterioration, contamination, adulteration or counterfeiting • Labeling or containers that seem to be incorrect.

  9. PMS PROGRAMME 2014-2017 Program have been selected based on the following criteria:- • Medicines for treating non-communicable diseases (NCDs), • Life saving medicines for women, children and infants( D • Medicines for treatment of neglected tropical diseases (NTDs),

  10. Phase II – Misoprostol, dexamethasone inj, ceftriaxone inj, gentamicin inj and dispersible zinc sulfate (MSD, 3 randomly selected private importers, randomly selected FOB/private hospital, district hospital and retail pharmacies) • Phase II is now complete and we didn’t find any quality problems on these products.

  11. Asanteni sana!

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