EAST AFRICAN COMMUNITY

1. JUMUIYA YA AFRIKA MASHARIKI EAST AFRICAN COMMUNITY Progress Report for Technical Working Group on Quality Management Systems Presented to 3rd Steering Committee Meeting, MRH Project, Bujumbura, 2-3 Sep 2013. By : Dr. Ronald Inyangala, B. Pharm., MSc., MPSK. Pharmacy & Poisons Board, Kenya

2. QMS Quote • "It is so counter-productive when the 'process' becomes the job vs. the 'process' of doing the job" – Unknown • Quality is free. It's not a gift, but it's free. The 'unquality' things are what cost money." - Philip B. Crosby

3. Presentation Outline • Objectives of the TWG on QMS • Composition of the TWG • Role of QMS & mode of delivery • Terms of Reference for the TWG on QMS • Major milestones for the TWG on QMS • Work accomplished • Work remaining • Factors influencing adjustments of projects schedule/Budget • Challenges • Conclusion

4. Objectives of the TWG on QMS • The overall objective of the TWG on QMS is to facilitate implementation of agreed common QMS requirements for regulation of medicines and ISO 9001 Certification of the NMRAs in the EAC Partner States. • At least three (3) NMRA’s ISO 9001 certified by the end of year three (3) of the project

5. Composition of the TWG on QMS The TWG is composed of: • 12 nominated Quality management experts drawn from all the 6 EAC Partner States’ NMRAs, • EAC Secretariat staff, • National Medicines Regulation Officers and, • AMRH Programme Partners: WHO & World Bank provides technical and administrative assistance respectively

6. ROLE OF QMS To establish, implement, maintain and continually improve the processes, systems and procedures of the quality management system of an NMRA in conformity with the relevant standards: • ISO 9001:2008 • ISO/IEC 17020: 2012 • ISO/IEC 17025:2005 • WHO & PIC/S guidelines. • and other applicable standards. Basis for EAC MRH QMS Requirements

7. Mode of delivery • The TWG conducts face to face and video conference meetings to jointly review and approve the documents and reports. So far the TWG has conducted; • 20 Video conferences • 4 Face-to-Face meetings

8. Terms of Reference for the TWG • Develop common QMS requirements for regulation of medicines, that shall include; development of Models for Quality Policy, Quality Manual, Systems level Standard Operating Procedures (SOPs) as per ISO standards and Process Maps . • Develop a Roadmap for implementation of QMS based on National or International recognized standards to be adopted by NMRAs’ QMS. • Compile and submit situation analysis on implementation of QMS by NMRAs and make recommendations to the Project’s Steering Committee.

9. Terms of reference..cont’d • Participate in the regional trainings on quality management and risk based approaches for regulatory decision making. • Participate in joint regular external quality assessments of NMRAs’ QMS in the Partner States. • Recommend to the project’s steering committee to advocate for domestication of the agreed QMS requirements/standards for NMRAs’ QMS. • Develop and submit Annual Work Plans and Budgets for the QMS TWG (AWPBs) for the TWG to the Project Steering Committee for review and approval

10. Major Milestones for the TWG on QMS Quality manual, processes and SOPs for EAC NMRAs’ QMS developed by year 2 At least one EAC’s NMRAs QMS Management meeting conducted annually At least one joint external QMS audit conducted per year Agreed common technical documents for QMS domesticated by end of year 3. At least 3 NMRAs receive ISO 9001 certification by end of year 3

11. Progress made EAC MRH - QMS Oriantation Training

12. Implementation of Requirements Nov 2013 -2014 Progress made Stakeholders Consultations, /2013 Oct, 2013 Editing of all requirements, guidelines, manuals & SOPs 4th F-F meeting, 15th-18th July, 2013 Lead Auditor training 8-12th July, 2013 QMS orientation training 4-6th July, 2013 3rd F-F meeting, 14th -18th January, 2013 1st F-F meeting 10-12th Sep, 2012, Nairobi 2nd F-F meeting 12th –14th Dec, 2012, Zanzibar 1st VC meeting in 11th July, 2012, followed by 19 others 2012 2014 2013 Year

13. Progress made by TWG for QMS Number of meetings held: • 20 video conference meetings • from July 2012 to July 2013 • 4 face to face meetings : • September 2012 (Nairobi) • December 2012 (Zanzibar) • January 2013 (Kigali) • July 2013 (Arusha)

14. Progress made ..2 Documents completed awaiting SC approval • The EAC QMS Requirements for the regulation of medicines, cosmetics, medical devices & diagnostics •  Guidelines for the implementation of  QMS in NMRA    •  Model Quality Manual for NMRA • Manual for development & control of EAC documents • Road map for the implementation of QMS - outlines implementation steps

15. Progress made..3 Documents completed awaiting SC approval..2 Model SOPs completed • Control of documents- internal &external • Control of records • Planning and conducting internal quality audits, establishing records and reporting results. • Controls of nonconforming products • Confidentiality and conflict of interest • Complaints and appeals • Corrective action & Preventive action • Conducting management review meetings

16. Progress made..4: QMS Training • Completed 3-day QMS orientation training. • 35 members of the EAC TWG on QMS & EAC Secretariat were trained. • Trainers were from Uganda NDA and TFDA. • Completed 5-day IRCA -certified ISO 9001:2008 Auditor/Lead auditor training course, with written examination on 5th day. • 20 members of the EAC TWG on QMS and EAC Secretariat were trained. • Two IRCA-certified auditors/trainers were from India

17. Work Remaining

18. Work remaining..2 • Regulatory process mapping and verification for NMRAs • Synchronize other EAC Procedures for other TWGs with EAC QMS requirements (e.g. Inspection and Medicines Registration Procedures,) • Develop an audit checklist based on EAC QMS Requirements

19. Work remaining..3 • Sensitization & training of NMRA management and staff on QMS • Training of more NMRA internal auditors • Conducting survey on NMRA service delivery – gap analysis & performance measurement • Oversee the implementation of EAC QMS requirements within NMRAs • QMS documents developed in all NMRAs

20. Work remaining..4 • Organize Training of NMRA staff on risk-based approaches • Coordinate Development and Implementation of EAC QMS Peer Auditing System (EQPA) • Planning for a workshop on sharing experience and best practices in Regulatory agencies: EU perspective

21. Work remaining..5 • Workshop on sharing experience and best practices in implementation of QMS in a medicines regulatory agencies: the EU perspective. • Participate in joint regular external quality assessment of NMRA's QMS in the EAC • Application for ISO 9001 certification by each EAC NMRA

22. Factors causing adjustment to the schedule or budget • Delayed recruitment of project staff • Lack of the required infrastructure in other partner states NMRA’s (Burundi, Rwanda & Zanzibar) • Delays in flow of funds to member states

23. Challenges • Harmonisation of the regulatory processes of all the six NMRAs. • Different implementation status & readiness • Resources allocation to QMS operations is limited • Resistance to change among NMRA staff • QMS is a new concept to most institutions • Lack of sector specific examples (i.e. Regulatory Authorities) for benchmarking • Balance between national regulatory requirements & meeting customer needs

24. Conclusion • Overall evaluation of the progress made during current reporting period, is very good. • Members of the TWG on QMS have acquired the necessary competence to take on the remaining tasks successfully. • The WB, WHO & the EAC Secretariat have been very supportive

25. Thank you very much – Asanteni Sana Mt. Kilimanjaro