5th - 7th november 2007 dar es salaam, tanzania1 who prequalification a kenyan experience dr. h.k....
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![Page 1: 5th - 7th November 2007 Dar es Salaam, Tanzania1 WHO prequalification A Kenyan experience Dr. H.K. Chepkwony, PhD Director, National Quality Control Laboratory](https://reader036.vdocuments.net/reader036/viewer/2022081519/56649ed35503460f94be2abb/html5/thumbnails/1.jpg)
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WHO prequalification A Kenyan experience
Dr. H.K. Chepkwony, PhDDirector, National Quality Control Laboratory (NQCL)
for Drugs and Medical Devices
Dr. E. Mbae, BPharmHead, Instrumentation and Wet Chemistry Units
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Outline
NQCL
Our prequalification process
Challenges
Conclusion
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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;
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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;
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Provide advisory services to the Ministry of Health on drug quality standards and quality assurance.
NQCL cont’d
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Wet Chemistry/Instrumentation Unit Physical Characteristics,
Uniformity of weight,
Uniformity of content,
Disintegration,
Friability,
Identification,
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Wet Chemistry/Instrumentation Unit cont’d
Assay (UV,Titration & HPLC),
Dissolution,
pH determination,
Polarimetry and
Viscosity.
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Biological Analysis Unit
Sterility testing,
Microbial limit testing
Bacterial endotoxin testing and
Microbiological Assay.
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Medical Device Unit
Condom Testing and
Surgical gloves testing.
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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.
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Why prequalification?
To realize our Vision:
Centre of excellence
International recognition
To authoritatively monitor and comment on the
quality of drugs.
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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.
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Our prequalification process
Need assessment
Strengths:
Adequate facilities
Motivated staff
Adequate equipment
Weaknesses:
Lack of documentation
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Our prequalification process cont’d
Opportunities:
Become a key player in drug quality control
Threats
Private Quality Control Laboratories
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Our prequalification process Cont’d The prequalification process started in February
2005.
Expression of interest by sending Laboratory
Information File (LIF) to WHO.
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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.
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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.
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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,
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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,
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Inventory Audit cont’d
No self inspection procedure and,
No restriction of access to the Laboratory.
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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,
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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,
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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.
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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),
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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.
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Conclusion
We are almost at the end of our journey.
“Journey of a thousands miles begins with a single step”
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Compliments
We would like to thank
Ministry of Health, GOK
WHO
Clinton Foundation
NQCL Board of Management and Staff
members
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Contact details
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: