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PRESENTATION TO THE 3RD MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP TWG

PRESENTATION TO THE 3RD MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP TWG 2-3 September 2013, Bujumbura, Burundi. Outline. Terms of Reference GMP TWG Composition Achievements Plan for the period Challenges. Terms of Reference. Harmonized legal framework for GMP

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PRESENTATION TO THE 3RD MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP TWG

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  1. PRESENTATION TO THE 3RD MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP TWG 2-3 September 2013, Bujumbura, Burundi Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

  2. Outline • Terms of Reference GMP TWG • Composition • Achievements • Plan for the period • Challenges

  3. Terms of Reference • Harmonized legal framework for GMP • Harmonized guidelines for GMP • Harmonized procedures, report format and templates for GMP • Harmonized GMP aide memoire/checklist • Harmonized procedure for planning, organizing, conducting and monitoring joint GMP inspections • Curricula and training materials, including e-learning • Harmonized procedure for qualification of GMP inspectors • Exchange of information on GMP inspections • Research on current best practices in the field of regulatoryinspections • Coordinate consultative meetings with all stakeholders

  4. Composition • Uganda (Chair) – Mrs Kate Kikule & Mr. Denis W. Mwesigwa • Burundi – Dr ServilienMpawenimana & G. Mukamisha • Kenya – Dr. Jacinta Wasike & Dr.ShabanSifuma • Rwanda – Mr. Joseph Kabatende & Ms Clarisse Irasaba • Tanzania (M) – Adonis Bitegeko & MwamwitwaKissa • Tanzania (Z) – Mr.M. Simbaand Mr.Ali Hamad

  5. Achievements • 14 video conferences • 3 face-to-face meetings • Kampala • Kigali • Bujumbura

  6. Achievements: Documents developed awaiting SC approval • Inspection Manual for Good Manufacturing Practice • Guidelines for GMP of medicinal products and related annexes • Guidelines on preparation of site master file for pharmaceutical manufacturing facilities • Guidelines on Training and Qualifications of GMP Inspectors • SOP for planning for GMP inspections. • SOP for preparing for a GMP inspection. • SOP for conducting a GMP inspection • SOP for preparing and reviewing a current good manufacturing practice inspection report • SOP for follow up on none compliances after GMP inspection • SOP for joint inspections • Questionnaire for assessment of Trainee Inspectors

  7. Achievements Under the WHO PQ-EAC Inspection Collaboration Procedure, NMRAs and WHO-PQ have continued to exchange inspection schedules through a secure website and inspectors from partner NMRAs have participated in joint inspections as co-inspectors Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

  8. Achievements Inspectors have used the prequalification program as a platform for capacity building at international level through participation in inspections as observers Inspectors from different NMRAs have participated in joint inspections within the region when other inspectors from partners NMRAs are inspecting facilities within their countries Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

  9. TFDA NDA ZFDA KPPB RWANDA

  10. Challenges Lack of mutually recognized legal frame work encompassing all the member state reduces the speed at which the TWGs are moving. Each member state has its own laws and regulations which are independent All the partner NMRAs are at a different level of medicine regulation and as a result moving at the as speed is still a challenge Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

  11. Way forward Plan for July 2013 to June 2014 has been developed Continuous, regular joint inspections with other international bodies, programs like the WHO pre-qualification program and other well resourced NMRAs is one of the methods the region will build capacity through a hands on approach Common database and a platform for sharing information which will guide regulatory decisions Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

  12. Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

  13. Thank you for listening Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi

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