Wubshet Mamo presented on the role of National Medicines Quality Control Laboratories (NMQCLs) and the potential for a regional network in the IGAD region. Key points include: - NMQCLs play a crucial role in identifying substandard, spurious, falsely-labeled, falsified, and counterfeit medical products through quality testing. - A regional network of NMQCLs could help build individual laboratory capacities, harmonize methodologies, and facilitate cross-border quality surveillance and information sharing. - Recommendations are made to promote the establishment of new NMQCLs, strengthen existing ones, implement quality management systems, and form a regional network body to coordinate

1. The First IGAD Member Countries Regulatory Authorities Conference on
Regulatory Collaboration and Possibility of Harmonization
3-5 August 2015, Hilton International Hotel
Addis Ababa, Ethiopia
Wubshet Mamo, DVM, PhD
Clinical Associate Professor of Global Health
Director, Clinical Laboratory System Development & Quality Improvement
I-TECH Ethiopia/University of Washington (2007 – 2015), USA
Principal Scientist, Drug Discovery Research
AstraZeneca Pharmaceuticals (1993 – 2007), Sweden
National Medicines Quality Control Laboratories (NMQCLs)
and Regional Networking Play Crucial Role in the
Identification of SSFFC Medical Products:
A model for IGAD Member Countries

2. Disclaimer
This presentation is based on the presenter’s expertise and
experience, does not reflect any official point of view. It
represents the views of the presenter for the purposes of the
First IGAD Member Countries Medicine Regulatory Authorities
Conference on Regulatory Collaboration and Possibility of
Harmonization, 3-5 August 2015, Hilton International Hotel,
Addis Ababa, Ethiopia.

3. Outline
 Drug (Medicine) Discovery Process
 Medicines Quality
 Poor Quality Medicine
 Impact of Poor Quality Medicine
 National Medicine Quality Control Laboratory (NMQCL)
 NMQCLs in IGAD region
 Regional (IGAD) NMQCLs Network
 Conclusions
 Recommendations

4. Drug (Medicine) Discovery Process

5. Medicine Quality
 Identity: Active ingredient (API)
 Purity: Not contaminated with potentially harmful substances
 Stability: Ensuring medicine activity for stated period
 Potency: Usually 90–110% of the labeled amount
 Bioavailability: Interchangeable products?
 Uniformity: Consistency of color, shape, size
Identity, purity, potency, uniformity are defined in
pharmacopoeias and stated in certificate of analysis (COA)
Determinants of medicine quality

6. How Is Medicine Quality Assured?
 Product Selection
Acceptable stability, bioavailability, long shelf-life
 Selection of Suppliers
Supplier pre-qualification
Request on specific reports and data (e.g., bioavailability
and stability studies)
Information on supplier performance
 Product Certification
GMP certificate of manufacturer
Product/batch certification (COA)
Random local testing
Medical products with poor quality are categorized as substandard/
Spurious/ Falsely-labeled /Falsified/ Counterfeit (SSFFC)

7. Substandard: Medicines that do not meet quality specifications
set for them (WHO) (excludes genuine manufacturing errors), but
may include intentional, reckless or negligent errors
Spurious: Terminology used in South Asia for products falsely
labelled or intended to deceive
Falsely labelled: Includes genuine product with false packaging
Falsified: European terminology to include a deliberate intention
to deceive
Counterfeit: Deliberate attempt to imitate a
genuine product, focus on IPR. There is no
universally agreed definition of counterfeit medicine
(WHO)
Poor Quality Medicines
SSFFC: Substandard/Spurious/Falsely Labelled/Falsified/Counterfeit

8. Poor-Quality Medicines
 Increased mortality and morbidity
 Cause drug resistance, loss of medicine efficacy
 Loss of confidence in health systems and health workers
 Economic loss for patients, their families, health systems, and
the producers and traders in good-quality medicines
 Adverse effects from incorrect active ingredients (APIs)
 Waste of enormous human effort and finance in development
of medicines, optimizing dosage, carrying out clinical trials,
discussing policy change, and manufacturing medicines
 Increased burden for health workers, medicine regulatory
authorities (MRAs), customs officials and police officers
Medicine quality Control Laboratories have the capacity to identify Poor quality medicines
Impact

9. Quality Control of Medicines
 NMQCLs are public institutions which support regulatory authorities
in controlling the quality of medical products for human and
veterinary use as well as identify illegal medical products available on
the market or intended to be on the market
 NMQCLs are separate and/or partially independent body from
the Regulatory Agency
National Medicine Quality Control Laboratories
 NMQCLs are prequalified for physical and chemical analysis
of medicines and active pharmaceutical ingredients (APIs). The
labs often have chemistry, microbiology and pharmacology units
and are equipped with state-
of-art equipment
(eg. Chromatograph,
Spectrometer, etc)

10.  In order to assure continued reliability of generated results,
the laboratory participates routinely in the WHO proficiency
testing (PT) scheme which enables it to compare performance
with other laboratories around the world
 NMQCLs play a key role in combating SSFFC products as they
provide final evidence for adulterations of medicines
 The work of NMQCLs has an impact on national, pan African and
international legislation and on other anti-counterfeit initiatives
 NMQCLs test (analysis) medicinal products independently from
manufacturers (no conflicts of interest, guarantee of impartiality,
respecting confidentiality).
National Medicine Quality Control Laboratory
(NMQCL)

11. Medicine Quality Control (Laboratories) In Sub
Saharan Africa (SSA)
 Access to reliable medical products quality testing is inadequate
in SSA region
 There are 5 WHO prequalified quality control laboratories exist
in SSA region
 Currently, 16 SSA countries are members of the Network of
African Medicine Quality Control Laboratories (NAMCOL),
established in 2009
 Currently, 33 SSA countries are an official or associate member
of the WHO Program for International Drug Monitoring (PIDM)
 Official Medicines Quality Control Laboratories of 4 SSA countries,
(Ethiopia, Ghana, and Nigeria, and Kenya) have received
ISO 17025 accreditation
Some Facts
ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories

12. Regional (IGAD) NMQCLs
Objective
Provide improved access to safe, effective and quality medicines
in the IGAD region. A regional approach.
 Analysis of substandard, counterfeit / illegal medicines (SSFFC)
 Pre-marketing sampling and analysis
 Post-approval (marketing) surveillance, sampling and testing
 Analysis of unlicensed (unauthorized) medicines
 Support in evaluation of the quality part of RA files
 Support of pharmacovigilance assessments
 Support of GMP inspections as experts
 Evaluation of quality defect reports
Roles:
(Experience from European, Official Medicines Control Laboratory, OMCL)
National Medicine Quality Control Laboratories
(NMQCLs) in IGAD Region

13.  Implementing comprehensive methods for analyzing the
quality of drug samples, techniques to increase laboratory
performance and improve drug analyses
 Promoting strategies and tools for increased data information
sharing with laboratories, regulatory authorities and other
national and international agencies
 Establishing and maintaining international accreditation
 Collaborate with customs, police, law court, health authorities
in questions of identification of falsified/illegal medicines, eg.
supporting forensic labs in complementary testing, acting as
technical experts in trials
 Training of professionals on medicines quality testing
National Medicine Quality Control Laboratories
(NMQCLs) in IGAD Region
Roles……….Cont’d

14. Regional (IGAD) NMQCLs Network
To promote the collaboration in the IGAD member countries in
the area of quality control of medicinal products, identify SSFFC
medicinal products and prevent them from reaching patients
Objective
Advantages:
 Increased expertise; pooling of know-how
 Organizing hands-on training for NMQCLs on substandard and
counterfeit medicines testing
 Creation of centers of expertise as testing becomes more and
more complex
 Cross border cooperation, e.g. to detect substandard,
counterfeited, illegal or low quality medicines and quick info
exchange

15.  Create a unified voice for feedback and exchange with
regulatory authorities, GMP inspectors, pharmacovigilance
experts, manufacturers and other stakeholders
 Strengthen the performance and technical skills of NMQCL staffs
 Promote communication and the exchange of information
 Harmonize methodologies to facilitate acceptance/recognition
 Ensure compliance with Good Laboratory Practices (GLP)
 Establish collaboration with continental and others (eg. European
OMCL net work, etc) Medicine Quality Control Laboratory
networks and organizations or government bodies
 Environmental protection, “less waste by sharing work”
Regional (IGAD) NMQCLs Network
Advantages……..cont’d

16.  Developing policies and rules (in collaboration with RAs),
procedures and guidelines
 Develop human resources
 Initiate/create expert groups
 Harmonized Quality Management Systems (QMS), ISO standard
 Establishing drug quality surveillance programs within NMQCLs
networking countries in order to control the quality of APIs and
medicinal products available on the IGAD countries market
 Offers inter-laboratory testing activities for participating labs to
improve laboratory performance
Regional (IGAD) NMQCLs Network
Tasks

17.  Promotes common QMS in all NMQCLs to enable their work-
sharing and mutual recognition of test results
 Scientific exchange on the level of working groups, plenary
meetings and symposia
 Establishing common test programs and promoting advanced
analytical testing method
 Mobilize concerted testing campaign
 Onsite medicine testing, eg. Minilab field testing kits
 SSFFC report, data pooled
Regional (IGAD) NMQCLs Network
Tasks……………cont’d
 Monitoring/checking the proficiency of the NMQCLs by PTS-
like program and enhancing by training as well as harmonize
their analysis methodologies

18.  Harmonization of the testing activities by use of common
standards, based on legal requirements
 Mutual recognition of test results
 Efficient cross-boarder, onsite testing, work sharing
 Simplified exchange of knowledge and expertise
 Data exchange, establishing knowledge of database that provides
linkage of information about SSFFC medicinal products generated
by NMQCLs, customs, police and health authorities via a common
database for regional NMQCLs networked countries
 A discussion platform for sharing scientific information and
strategies
 Concerted activity of the NMQCLs through the NMQCLs network
Regional (IGAD) NMQCLs Network
Possible Goals:

19. Human Resources
 Advisory Group
 Plenum (decision)
 Expert Groups
 Secretariat (coordination)
Policies and Rules
 Terms of Reference
 Procedures
 Guidelines
Regional (IGAD) NMQCLs Network
Ref: EDQM (R wanko), www.edqm.eu
Foundation Pillars
Harmonized Quality Management System (QMS)
On basis of the ISO/IEC 17025 standard

20. Educational Programs
• Technical, QMS training &
curriculum development
• Training on IT tools
• Training visits to
laboratories
IT Platforms
• IT (dissemination of information,
documents, reports…)
• Databases (exchange of information
on technical competencies, test
results…)
Surveillance of the Quality Management Systems (QMS)
• Programs to support the implementation of QMS
• Audit program (equivalent to accreditation)
• Proficiency Testing Studies (PTS)
• Quality guidelines to complement ISO17025
Regional (IGAD) NMQCLs Network
Coordination Tools
Ref: EDQM (R wanko), www.edqm.eu

21. Conclusion
 The overall quality of a medical product in the IGAD region,
relies upon a number of approaches where the analytical
experience and capability of NMQCLs plays a critical role
 Independent and active pre marketing sampling and analysis
and post-marketing surveillance, sampling and testing by the
individual NMQCLs is fundamental
 Strong cooperation between NMQCL experts, quality assessors,
GMP inspectors is critical for the common goal of a better quality
and more controlled drugs and medical products
 A strategy for establishment of a network of NMQCLs in IGAD
countries is of great advantage for the surveillance, identification
and control of SSFFC medical products and also in building testing
capacities of individual NMQCLs

22. Conclusion..…….cont’d
 Regional (IGAD) NMQCLs network can play critical role in
building testing capacities of individual NMQCLs
 Human resource capacity building
 Harmonization of testing methodologies, mutual recognition
of test results
 Medicine quality control tests at cross boarder sites utilizing
simple and mobile testing technologies (eg. Minilabs,..) is vital
 Participating in WHO’s prequalification programs and meeting
standards commended is critical
 NMQCLs should be of high standards, with updates
technologies, skills and efficient collaboration/networking

23.  Promoting medicine quality control laboratories in all IGAD
member countries, establishing new and, strengthening existing
laboratories
 QMS: Building capacity of medicine quality assurance QA and QC
systems in all IGAD member countries (joining WHO
prequalification program, international accreditation, ISO 17025)
 Creating regional medicine quality control laboratories
network between IGAD member countries
 Creation of Regional Center of Excellence (RCoE), center of
expertise, reference and training center for NMQCLs
 Participating in Regulatory Science Education
Recommendations
 Creating expert (working) group (Task force, coordination body)
facilitated by IGAD with active participation of member states
and key partners

24. SSFFC medical products are “silent weapons”
killing several hundred thousands of innocent
patients every year,
can be controlled & prevented!
A shared responsibility!

25. Thank You for Your Attention!Thank You for Your Attention!