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Africa Pharmaceutical Conference Johannesburg, 5 June 2019

This conference in Johannesburg on 5 June 2019 will cover UNIDO's GMP Roadmap Approach and Pilot Level Implementation of Lean Six Sigma by Alastair West. It will discuss the rationale behind GMP requirements, the stepwise approach to compliance, and tools used for implementation. The event will explore case studies from Kenya, Ghana, and Zimbabwe, as well as the Regional GMP Roadmap Framework for ECOWAS countries. The presentation will also delve into the pilot scale Lean Six Sigma training in Kenya and its impact on cost reduction and profit improvement in pharmaceutical manufacturing. Attendees will gain insights on how the GMP roadmap approach and Lean Six Sigma methodologies can help companies achieve international compliance standards and enhance operational efficiency.

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Africa Pharmaceutical Conference Johannesburg, 5 June 2019

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  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.

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