PRESENTATION TO THE NATIONAL STAKEHOLDERS MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP...
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Transcript of PRESENTATION TO THE NATIONAL STAKEHOLDERS MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE GMP...
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PRESENTATION TO THE NATIONAL STAKEHOLDERS
MEETING OF THE EAC REGIONAL STEERING COMMITTEE BY THE
GMP TWG
Presented by:
Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi
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OutlineTerms of Reference GMP TWGObjectivesCompositionAchievementsPlan for the periodChallenges
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Terms of ReferenceHarmonized legal framework for GMPHarmonized guidelines for GMPHarmonized procedures, report format and templates
for GMPHarmonized GMP aide memoire/checklistHarmonized procedure for planning, organizing,
conducting and monitoring joint GMP inspectionsCurricula and training materials, including e-learningHarmonized procedure for qualification of GMP
inspectorsExchange of information on GMP inspectionsResearch on current best practices in the field of
regulatory inspectionsCoordinate consultative meetings with all
stakeholders
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Objectives of establishing EAC GMPTwo regional centres of excellence in
training on assessor and GMP inspector established in the EAC region by end of year five (5) of the project
Twenty five (25) EAC and NMRA MRH project staff trained on project management by end of year five (5)
Twenty four (24) assessor trained in assessment of quality, safety and efficacy of medicines by the end of year five (5)
Twenty four (24) inspectors trained on GMP inspection by end of year five (5)
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CompositionThe technical working group is chaired
by the Re public of Uganda(Chair) Is composed of twelve members drawn
from the six NMRAs of the Republics of Burundi, Kenya, Rwanda , Uganda and The United Republic of Tanzania (Mainland) and Tanzania (Zanzibar)
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Achievements14 video conferences
3 face-to-face meetings- Kampala- Kigali- Bujumbura
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Achievements: Documents developed and which Project Steering Council 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
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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 EAC Partner States NMRAs have participated in joint inspections as co-inspectors
Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi
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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 States Partners NMRAs are inspecting facilities within their countries
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10
TFDA NDAZFDA
KPPB
RWANDA
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Challenges Lack of mutually recognized legal frame work encompassing all the Partner States reduces the speed at which the TWGs are moving. Each Partner State has its own laws and regulations that are independent
All the Partner States 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
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Request to the National Stakeholders
Inspection Manual for Good Manufacturing PracticeGuidelines for GMP of medicinal products and related
annexesGuidelines 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 inspectionSOP for preparing and reviewing a current good
manufacturing practice inspection reportSOP for follow up on none compliances after GMP inspection SOP for joint inspections 12
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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
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Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi
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Thank you for listening
Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi