Transcript Document
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
Outline
Terms of Reference GMP TWG
Objectives
Composition
Achievements
Plan for the period
Challenges
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 regulatory
inspections
Coordinate consultative meetings with all stakeholders
Objectives of establishing EAC
GMP
Two 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)
Composition
The 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)
Achievements
14
3
video conferences
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
TFDA
NDA
ZFDA
KPPB
RWANDA
10
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 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
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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 prequalification 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
listening
Uganda, Kenya, United Republic of Tanzania, Rwanda, Burundi
for