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

OutlineTerms of Reference GMP TWGObjectivesCompositionAchievementsPlan for the periodChallenges

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

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)

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)

Achievements14 video conferences

3 face-to-face meetings- Kampala- Kigali- Bujumbura

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

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

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

10

TFDA NDAZFDA

KPPB

RWANDA

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

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

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

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

Thank you for listening

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