The functions of this department are to inspect the following:
- Pharmaceutical Manufacturers
Purpose:
To ensure that all drug-handling operations are being supervised by authorized (registered) persons and those comply with statutory requirements.
Activities:
NDA inspectors inspect the premises and evaluate practices to ensure that the required provisions for licensing are being complied in the Drug outlets. Inspection Checklists are used to ensure standardized and comprehensive assessment.
Inspection of Imported Drugs
Purpose:
To ensure that imported drugs:
- comply with import requirements (i.e. are registered drugs from approved sources)
- are of the identity, quantity and quality described on the related ProForma Invoice
Activities:
Inspectors are based at the main ports of entry and examine imported drug consignments to ensure that they comply with requirements prior to granting NDA clearance of the shipment. Note: Customs clearance must also be obtained before the drugs can be finally cleared for import into the country.
Ports of entry are:
- Entebbe International Airport
- Busia/Malaba Border points
- Others are; Main Post Office, Bus terminals, Railway station and other customs authorized ports of entry.
cGMP Inspections (cGMP audits)
Purpose:
To ensure that the manufacturing facilities of drugs to be imported into Uganda operate according to international standards for current Good Manufacturing Practice (cGMP). This is to ensure that drug quality is maintained throughout the entire production process.
Activities:
Specially trained senior Drug Inspectorate staffs visit pharmaceutical manufacturing facilities both inside and outside Uganda and carry out a detailed and comprehensive assessment of all manufacturing operations.
Aims, Objectives and Strategies
objective 1: To ensure effective regulation of the human and veterinary pharmaceutical sector including traditional/herbal medicine
Strategies:
- To Strengthen the capacity of the Inspectorate Department
- To Revise licensing regulations and ensure effective implementation.
- To develop and publish operational guidelines and regulations.
Aims:
To notify and sensitize pharmaceutical proprietors in licensing Procedures every year.
Activities:
- Inspection of drug outlet premises i.e. pharmacies and drug shops.
- Process and distribute licenses of various drug outlets.
- Carry out support supervision in all districts at least once a year.
- Develop and review Sops and guidelines for the department's procedures and operations.
Objective 2: To Promote local production of 'essential human and veterinary medicines (including traditional/herbal medicine)
Strategies:
- To Promote efforts of providing a conducive environment for the development of local pharmaceutical manufacturing
- Assist and monitor local pharmaceutical manufacturers to develop and maintain required technical capacity.
Aims:
Initiate talks for incentives for the local pharmaceutical manufacturers.
Activities:
- Identify training opportunities for key production and QA/QC
- Personnel of local manufacturers.
- Provide expertise to local manufacturers in identified technical areas e.g. cGMP, validation.
- Carry out regular inspection of local manufacturing facilities.
- Develop, update, publish and distribute guidelines for local manufacturers.
Objective 3: To ensure effective control over the quality, safety and efficacy of all human and veterinary medicines available in the country in order to protect the end use.
Strategies:
Ensuring that only authorized human and veterinary medicines are available in Uganda.
Aims:
- Carryout drug surveillance in all the districts of Uganda.
- Inspect human & veterinary drugs, sundries and medical equipment at the ports of entry.
- Monitor record keeping in drug outlets.
Relevant downloadable documents(pdf)
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