WHO prequalification A Kenyan experience

1. WHO prequalificationA Kenyan experience Dr. H.K. Chepkwony, PhD Director, National Quality Control Laboratory (NQCL) for Drugs and Medical Devices Dr. E. Mbae, BPharm Head, Instrumentation and Wet Chemistry Units Dar es Salaam, Tanzania

2. Outline • NQCL • Our prequalification process • Challenges • Conclusion Dar es Salaam, Tanzania

3. NQCL Established as a Body Corporate by an Act of Parliament in 1992. It is a testing facility mandated to: • Check the quality of drugs and medicinal substances; • Perform physical, chemical, biological and other pharmaceutical evaluation on drugs and medicinal substances; Dar es Salaam, Tanzania

4. NQCLcont’d • Test, at the request of the Pharmacy and Poisons Board and on behalf of the Government, the quality of locally manufactured and imported drugs or medicinal substances with a view to determining whether such drugs or medicinal substances comply with specifications of official compendia and; Dar es Salaam, Tanzania

5. NQCL cont’d • Provide advisory services to the Ministry of Health on drug quality standards and quality assurance. Dar es Salaam, Tanzania

6. Wet Chemistry/Instrumentation Unit • Physical Characteristics, • Uniformity of weight, • Uniformity of content, • Disintegration, • Friability, • Identification, Dar es Salaam, Tanzania

7. Wet Chemistry/Instrumentation Unit cont’d • Assay (UV,Titration & HPLC), • Dissolution, • pH determination, • Polarimetry and • Viscosity. Dar es Salaam, Tanzania

8. Biological Analysis Unit • Sterility testing, • Microbial limit testing • Bacterial endotoxin testing and • Microbiological Assay. Dar es Salaam, Tanzania

9. Medical Device Unit • Condom Testing and • Surgical gloves testing. Dar es Salaam, Tanzania

10. Our Clients • Pharmacy and Poisons Board, • Government Agencies: • Government Hospitals • Kenya Medical Supplies Agency and • Special programs e.g. NASCOP • Non-Government Agencies and • Private sector: • Pharmaceutical manufacturing industries, • Private hospitals and • Drug distributors. Dar es Salaam, Tanzania

11. Why prequalification? • To realize our Vision: • Centre of excellence • International recognition • To authoritatively monitor and comment on the quality of drugs. Dar es Salaam, Tanzania

12. Why WHO prequalification? • The international body concerned with health matters, • Actively seeking to have national quality control laboratories prequalified, • The process is: • Free • Simple and • Achievable. Dar es Salaam, Tanzania

13. Our prequalification process • Need assessment • Strengths: • Adequate facilities • Motivated staff • Adequate equipment • Weaknesses: • Lack of documentation Dar es Salaam, Tanzania

14. Our prequalification process cont’d • Opportunities: • Become a key player in drug quality control • Threats • Private Quality Control Laboratories Dar es Salaam, Tanzania

15. Our prequalification process Cont’d • The prequalification process started in February 2005. • Expression of interest by sending Laboratory Information File (LIF) to WHO. Dar es Salaam, Tanzania

16. Our prequalification process Cont’d • Prepared for the Inventory Audit by: • Documenting our procedures, • Ensuring our procedures follow the Good Practices for National Pharmaceutical Control Laboratories and • Initiating a preventive maintenance process. Dar es Salaam, Tanzania

17. Inventory Audit • In early July 2005. • Major findings: • The staff were knowledgeable and highly motivated and • There was a well-defined system of procedures of carrying out various tasks. Dar es Salaam, Tanzania

18. Inventory Audit cont’d • Major shortcomings: • No Quality Manual and accompanying SOPs, • No program for staff training, • No environmental monitoring, • The organization chart and job descriptions were not detailed enough, Dar es Salaam, Tanzania

19. Inventory Audit cont’d • No calibration and maintenance schedules for equipment, • No equipment qualification records, • No data management and document control system, • No procedure for handling OOS and failed analyses, Dar es Salaam, Tanzania

20. Inventory Audit cont’d • No self inspection procedure and, • No restriction of access to the Laboratory. Dar es Salaam, Tanzania

21. Corrective Actions • Development of a quality manual, • Drafting, review and approval of SOPs, • Initiation of a program to update and upgrade our equipment, • Renovation of the premises, • Recruitment of new staff members, • Retrograde Qualification of the HPLC machines, Dar es Salaam, Tanzania

22. Corrective Actionscont’d • Development of calibration and maintenance schedules, • Development of a detailed organization structure, • Updating of job descriptions, • Implementation of processes identified in the quality manual, Dar es Salaam, Tanzania

23. Pre-Inspection Audit • In May 2007. • Main observations: • A detailed quality manual in place but still under implementation and • A need to carry out regular self inspections. Dar es Salaam, Tanzania

24. Challenges • Development of a Quality Manual, • Drafting of SOPs, • A need for radical change of our procedures, • The equipment did not have qualification documentation, • Waste management, • Premises (Inadequate space), Dar es Salaam, Tanzania

25. Challenges cont’d • Requirements were sometimes above the experience of the staff members, • Input required from senior personnel in our Ministry of Health, • Limited financial resources and • Personnel. Dar es Salaam, Tanzania

26. Conclusion • We are almost at the end of our journey. “Journey of a thousands miles begins with a single step” Dar es Salaam, Tanzania

27. Compliments • We would like to thank • Ministry of Health, GOK • WHO • Clinton Foundation • NQCL Board of Management and Staff members Dar es Salaam, Tanzania

28. Hospital Road, KNH Complex, University of Nairobi, School of Pharmacy Building, 2nd Floor. P. O. Box 29726-00202, Nairobi, Kenya. Tel: +254 020 2726963 +254 020 3544525 +254 020 3544530 +254 020 3544522 Fax: +254 020 2718073 E-mail: info@nqcl.go.ke Contact details Dar es Salaam, Tanzania