1. Africa Pharmaceutical Conference
Johannesburg, 5 June 2019
UNIDO´s GMP Roadmap Approach and Pilot Level implementation of Lean Six Sigma
Alastair West
PMPA Business Plan Coordinator 1

2. Contents GMP Roadmap Lean Six Sigma Conclusions. Rationale
Overview of Approach
Regional GMP Roadmap Framework - ECOWAS
Results from initial reclassification in Kenya
Lean Six Sigma
Conclusions.

3. GMP Roadmap Rationale
Level of compliance to internationally recognised GMP varies
GMP requirements can be daunting and cannot be achieved overnight
Need to support countries and regions to establish a pathway to compliance for all manufacturers
Stepwise, risk based approach towards achieving compliance developed
During transition, mitigation of risk to product quality is essential

4. Design and implementation of GMP roadmap utilses consistant tools and approach - central component is classifiation matrix
A: Existing approach towards pharmaceutical manufacturing in general in line with WHO GMP requirements  low risk manufacturer
B: Existing approach towards pharmaceutical manufacturing not in line with WHO GMP but reduced risk with regards to production safety  medium risk manufacturer
C: Existing approach towards pharmaceutical manufacturing not in line with WHO GMP and high risk with regards to production safety  high risk manufacturer

5. Based on Findings a 2 Phase roadmap has been appropriate to date.
For each phase detailed technical milestones established.

6. Technical aspects of implementation include:
Assessment of all active manufacturers
Training on GMP and CAPA development
CAPA reiew and CAPA clinics
Support to regulatory body for monitoring CAPA implementation and as appropriate, reassessment.

7. GMP Roadmap approach has been utilised in a number of settings
Roadmaps developed for Kenya, Ghana and Zimbabwe.
Methodology utilised to support NSPA in Ethiopia
Approach endorsed by the AMRH for regional initiatives
Just finishing the first phase of a
Regional GMP Roadmap Framework
project for the ECOWAS region
(includes 15 national approaches
alligned to the regional framework)

8. The Regional Framework was validated at a workshop in Abidjan last November

9. A long term Relationship Agreement was signed with WAHO on 27th May 2019
Includes:
Implementation of GMP roadmap framework
Support for development of pharmaceutical sector in West Africa

10. In Kenya 8 companies were reassessed 3 years into RM implementation
2015
2018
Reclassifications - summary
One company maintained its A rating
Two companies* were upgraded to an A rating
Two companies were upgraded to a B rating
Three B rated companies did not improve sufficiently to be upgraded and remain at B level A 1 3* A B 5 5 B C 2 C
* Includes 1 company required to submit updated CAPA in order to be upgraded

11. Pilot Scale Lean Six Sigma training of trainers implemented in Kenya
Economics of the industry are complex
However, application of efficient production approaches such as lean six sigma can reduce costs/improve profits
Focal points in 6 companies in Kenya mentored in application of LSS on one selected component of the production process
Idea to coach champion who can lead appllication in company more broadly
Even on individual components results were signifiicant. One company reported $400,000 p/a in cost reduction

12. Conclusion
The GMP roadmap appproach has been shown to be valuable in helping companies to upgrade towards internationally recognised GMP
It is one key part of a strategic approach, but requires other issue to be addressed
Utilising Lean Six Sigma has been shown to enable significant cost savings.