Africa Pharmaceutical Conference Johannesburg, 5 June 2019

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 a.west@unido.org 1

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

3. GMP Roadmap Rationale • Level of compliance to internationallyrecognised GMP varies • GMP requirements can bedaunting and cannotbeachievedovernight • Need to support countries and regions to establish a pathway to compliance for all manufacturers • Stepwise, riskbasedapproachtowardsachieving compliance developed • During transition, mitigation of risk to productqualityis essential

4. Design and implementation of GMP roadmap utilses consistant tools and approach - central component isclassifiation 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 roadmaphasbeenappropriateto date. Foreachphasedetailedtechnicalmilestonesestablished.

6. Technical aspectsofimplementationinclude: • Assessment of all activemanufacturers • Training on GMP and CAPA development • CAPA reiew and CAPA clinics • Support toregulatorybodyformonitoring CAPA implementation and asappropriate, reassessment.

7. GMP Roadmap approachhasbeenutilised in a numberofsettings • Roadmaps developedforKenya, Ghana and Zimbabwe. • Methodologyutilisedto support NSPA in Ethiopia • Approach endorsedbythe AMRH for regional initiatives • Just finishingthefirstphaseof a Regional GMP Roadmap Framework projectforthe ECOWAS region (includes 15 national approaches allignedtothe regional framework)

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

9. A long term Relationship Agreement wassignedwith WAHO on 27th May 2019 Includes: Implementation of GMP roadmap framework Support for development of pharmaceuticalsector 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 • Twocompanies* were upgraded to an A rating • Twocompanies 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 B 5 5 C 2 C 0 * Includes 1 company required to submit updated CAPA in order to be upgraded

11. Pilot Scale Lean Six Sigma trainingoftrainersimplemented in Kenya • Economics oftheindustryarecomplex • However, applicationofefficientproductionapproaches such asleansixsigmacanreducecosts/improveprofits • Focalpoints in 6 companies in Kenyamentored in applicationof LSS on oneselectedcomponentoftheproductionprocess • Ideatocoachchampionwhocanleadappllication in companymorebroadly • Even on individual componentsresultsweresignifiicant. Onecompanyreported $400,000 p/a in costreduction

12. Conclusion • The GMP roadmapappproachhasbeenshowntobevaluable in helpingcompaniesto upgrade towardsinternationallyrecognised GMP • Itisonekeypartof a strategicapproach, but requiresotherissuetobeaddressed • Utilising Lean Six Sigma hasbeenshowntoenablesignificantcostsavings.