1. Quality Control Laboratories; Challenges from A Regulatory perspective
Presented by
Ms. Annette Bukirwa Ssenkindu
Manager Medicines, NDA
Date : 07th Nov 2017

2. Presentation Outline Brief Background about Uganda
Scope of Drug Regulation, Mission and Vision
NDA Organogram and HR capacity
NDQCL Laboratory operations
Challenges – Regulatory perspective

3. Brief Background About Uganda
Located in East Africa
Capital city- Kampala
Population : approx 35m
Uganda is a land locked country- access to the sea is by Mombasa port- Kenya and Tanzania (Dar –es- Salaam port).
Has a tropical climate ; approx 18̊C-33̊C throughout the year.
Official language- English

4. Brief Background About NDA NDP/A Act
National Drug Authority (NDA) was established by an Act of Parliament in 1993 currently the National Drug Policy and Authority (NDP/A) Act, Cap. 206 of the Laws of Uganda (2002 Revised edition).
One of the major functions is to control the quality of drugs and ensure that drugs used in Uganda are safe, efficacious and of good quality.
NDA reports to the Minister of Health; It has a board of Directors and a Secretariat.

5. NDA Headquarters, Lumumba Avenue , Kampala

6. Vision and Mission
Vision : To become a World Class Regulatory Agency effectively protecting and promoting Public Health MISSION To ensure access to quality, safe and efficacious human and veterinary medicines and other healthcare products through the regulation and control of their production, importation and use.

7. Organogram of the NDA Secretariat
Secretary to the Authority
Directorate of Drug Inspectorate & Enforcement
Directorate of Drug Assessment & Registration
Directorate of Laboratory Services
Directorate of Corporate Services
Directorate of Product Safety
Departments
Legal Services
Quality Manager
Public Relations
Information Technology
Procurement
Food Desk Coordinator
Regional Inspectorate Offices
Approx. 200 employees 7

8. Scope of Drug Regulation(1) Introduction
Scope of regulation is in the definition of a drug:
Any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes.
Products regulated:
Human Pharmaceuticals, Biologicals & Vaccines
Veterinary Pharmaceuticals, Biologicals & Vaccines
Nutritional substances
Herbal Medicines
Medical devices, Diagnostics and Sundries
Public Health Chemicals

9. Directorate of Laboratory Services
NDA- NATIONAL DRUG QUALITY CONTROL LABORATORY

10. NDA-NDQCL laboratory

11. NDA-NDQCL LAB
It is situated at Mulago Hill near the main referral hospital.
Category of samples tested ; medicine samples ( human and veterinary), medical devices such as male latex condoms , medical gloves, and Public Health Products such as LLINs, insecticides , pesticides .
Lab has approx 30 persons in total.

12. Laboratory Structure The laboratory has 3 major units :
Medicine laboratory/ unit
Medical device laboratory / unit
Quality management unit.
Each unit is headed by a Manager

13. NDA-NDQCL Medicine Laboratory

14. QA Testing Strategies
Pre- market testing of samples for local manufacturers .
Post market testing of samples from the NDA regions (7)
Post shipment testing at ports of entry; Routine / mandatory testing

15. Achievements
Two laboratory premises in place; fairly equipped with modern equipment such as FTIR, HPLC, GC , Auto- Titrators.
Laboratory Quality management system (LQMS ) is in place and the medicine laboratory is WHO prequalified since January 2015.
Laboratory is ISO accredited since end of March this year for the Medical Device Lab & scope is being expanded to other areas.

16. Achievements
The laboratory participates in Proficiency testing ( PTs) organized by different bodies i.e WHO for medicines, EAC-PTB, Enersol, Australia and FHI, USA for medical devices.
Number of samples being tested & no. of medicine categories have expanded over years; currently approx samples are tested annually.

17. Achievements cont.
Microbiology laboratory has been established; estimated to be functional by the end of this FY .
A new building with a fully fledged laboratory tower is to be established at Lumumba Avenue . To be kick started this FY .

18. NDA proposed new building

19. Testing Methodologies
A: Medicines
Use of Minilab testing Kits
Truscan Device
Use of Modern Techiniques eg. FTIR, HPLC, GC , Autotitrimetry .
B: Medical Devices
Physical testing- Air Burst , leak testers, tensile tests etc.

20. GPHF Minilab Testing kit

21. Use of Truscan device

22. Testing using HPLC
- Used to test antimalarial medicines, ARVs, anti – TBs among others including PermaNet LLINs.

23. (Regulatory Perspective).
Challenges
(Regulatory Perspective).

24. Challenges
Lack of adequate CRS ( assay, Impurities etc )to cater for all categories of medicines.
Lack of adequate numbers of testing equipment.
Some equipment lacks modern data traceability /security requirements.
Lack of adequate numbers of human resources.

25. Challenges cont
Delays in procurement of laboratory consumables.– follows PPDA law and regulations.
Unplanned samples ( eg. complaint samples ) for testing.
Lack of adequate capacity as a country to carry out calibration/ qualification/ maintenance for all laboratory equipment eg. HPLC, GC .
In – House methods Vs Pharmacopeia methods- Validation / verification of methods

26. Challenges
Lack of regional laboratories
Lack of adequate resources

27. Tourism :Uganda’s Wildlife

28. Source of the NILE

29. A Nile -Jump

30. End
Welcome to the Pearl of Africa!.
God Bless you!