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

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

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

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.

NDA Headquarters, Lumumba Avenue , Kampala

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.

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

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

Directorate of Laboratory Services NDA- NATIONAL DRUG QUALITY CONTROL LABORATORY

NDA-NDQCL laboratory

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.

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

NDA-NDQCL Medicine Laboratory

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

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 17025 accredited since end of March this year for the Medical Device Lab & scope is being expanded to other areas.

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. 1200-1500 samples are tested annually.

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 .

NDA proposed new building

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.

GPHF Minilab Testing kit

Use of Truscan device

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

(Regulatory Perspective). Challenges (Regulatory Perspective).

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.

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

Challenges Lack of regional laboratories Lack of adequate resources

Tourism :Uganda’s Wildlife

Source of the NILE

A Nile -Jump

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