5th - 7th November 2007 Dar es Salaam, Tanzania1 WHO prequalification A 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

5th - 7th November 2007 Dar es Salaam, Tanzania2 Outline NQCL Our prequalification process Challenges Conclusion

5th - 7th November 2007 Dar es Salaam, Tanzania3 NQCL Established as a Body Corporate by an Act of Parliament in 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;

5th - 7th November 2007 Dar es Salaam, Tanzania4 NQCL cont’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;

5th - 7th November 2007 Dar es Salaam, Tanzania5 Provide advisory services to the Ministry of Health on drug quality standards and quality assurance. NQCL cont’d

5th - 7th November 2007 Dar es Salaam, Tanzania6 Wet Chemistry/Instrumentation Unit  Physical Characteristics,  Uniformity of weight,  Uniformity of content,  Disintegration,  Friability,  Identification,

5th - 7th November 2007 Dar es Salaam, Tanzania7 Wet Chemistry/Instrumentation Unit cont’d  Assay (UV,Titration & HPLC),  Dissolution,  pH determination,  Polarimetry and  Viscosity.

5th - 7th November 2007 Dar es Salaam, Tanzania8 Biological Analysis Unit  Sterility testing,  Microbial limit testing  Bacterial endotoxin testing and  Microbiological Assay.

5th - 7th November 2007 Dar es Salaam, Tanzania9 Medical Device Unit  Condom Testing and  Surgical gloves testing.

5th - 7th November 2007 Dar es Salaam, Tanzania10 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.

5th - 7th November 2007 Dar es Salaam, Tanzania11 Why prequalification? To realize our Vision:  Centre of excellence  International recognition To authoritatively monitor and comment on the quality of drugs.

5th - 7th November 2007 Dar es Salaam, Tanzania12 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.

5th - 7th November 2007 Dar es Salaam, Tanzania13 Our prequalification process Need assessment  Strengths:  Adequate facilities  Motivated staff  Adequate equipment  Weaknesses:  Lack of documentation

5th - 7th November 2007 Dar es Salaam, Tanzania14 Our prequalification process cont’d  Opportunities:  Become a key player in drug quality control  Threats  Private Quality Control Laboratories

5th - 7th November 2007 Dar es Salaam, Tanzania15 Our prequalification process Cont’d The prequalification process started in February Expression of interest by sending Laboratory Information File (LIF) to WHO.

5th - 7th November 2007 Dar es Salaam, Tanzania16 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.

5th - 7th November 2007 Dar es Salaam, Tanzania17 Inventory Audit In early July Major findings:  The staff were knowledgeable and highly motivated and  There was a well-defined system of procedures of carrying out various tasks.

5th - 7th November 2007 Dar es Salaam, Tanzania18 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,

5th - 7th November 2007 Dar es Salaam, Tanzania19 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,

5th - 7th November 2007 Dar es Salaam, Tanzania20 Inventory Audit cont’d  No self inspection procedure and,  No restriction of access to the Laboratory.

5th - 7th November 2007 Dar es Salaam, Tanzania21 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,

5th - 7th November 2007 Dar es Salaam, Tanzania22 Corrective Actions cont’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,

5th - 7th November 2007 Dar es Salaam, Tanzania23 Pre-Inspection Audit In May Main observations:  A detailed quality manual in place but still under implementation and  A need to carry out regular self inspections.

5th - 7th November 2007 Dar es Salaam, Tanzania24 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),

5th - 7th November 2007 Dar es Salaam, Tanzania25 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.

5th - 7th November 2007 Dar es Salaam, Tanzania26 Conclusion We are almost at the end of our journey. “Journey of a thousands miles begins with a single step”

5th - 7th November 2007 Dar es Salaam, Tanzania27 Compliments We would like to thank  Ministry of Health, GOK  WHO  Clinton Foundation  NQCL Board of Management and Staff members

5th - 7th November 2007 Dar es Salaam, Tanzania28 Contact details Hospital Road, KNH Complex, University of Nairobi, School of Pharmacy Building, 2 nd Floor. P. O. Box , Nairobi, Kenya. Tel: Fax: