5th - 7th November 2007 Dar es Salaam, Tanzania1 WHO prequalification A Kenyan experience Dr. H.K....

5th - 7th November 2007 Dar es Salaam, Tanzania 1

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


Outline

NQCL

Our prequalification process

Challenges

Conclusion


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;


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;


Provide advisory services to the Ministry of Health on drug quality standards and quality assurance.

NQCL cont’d


Wet Chemistry/Instrumentation Unit Physical Characteristics,

Uniformity of weight,

Uniformity of content,

Disintegration,

Friability,

Identification,


Wet Chemistry/Instrumentation Unit cont’d

Assay (UV,Titration & HPLC),

Dissolution,

pH determination,

Polarimetry and

Viscosity.


Biological Analysis Unit

Sterility testing,

Microbial limit testing

Bacterial endotoxin testing and

Microbiological Assay.


Medical Device Unit

Condom Testing and

Surgical gloves testing.


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.


Why prequalification?

To realize our Vision:

Centre of excellence

International recognition

To authoritatively monitor and comment on the

quality of drugs.


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.


Our prequalification process

Need assessment

Strengths:

Adequate facilities

Motivated staff

Adequate equipment

Weaknesses:

Lack of documentation


Our prequalification process cont’d

Opportunities:

Become a key player in drug quality control

Threats

Private Quality Control Laboratories


Our prequalification process Cont’d The prequalification process started in February

2005.

Expression of interest by sending Laboratory

Information File (LIF) to WHO.


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.


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.


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,



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,



No self inspection procedure and,

No restriction of access to the Laboratory.


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,


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,


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.


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),


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.


Conclusion

We are almost at the end of our journey.

“Journey of a thousands miles begins with a single step”


Compliments

We would like to thank

Ministry of Health, GOK

WHO

Clinton Foundation

NQCL Board of Management and Staff

members


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:

[email protected]

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