2. INTRODUCTION
The World Health Organization is the United
Nations specialized agency for health.
Established on 7 th April 1948 . Governed by
192 Member States through the World Health
Assembly. Countries which are members of the
United Nations may become members of WHO
3. HISTORY
• First global health organization. In latter half of
19 th century, severe cholera epidemics was
occurred. At that time, series of international
sanitary conferences were held in Europe to co-
ordinate policy & practice around quarantine &
disease management. The League of Nations
established a health organization in 1920
having also regional bodies
4. Establishment
• Establishment of the United Nations in 1945 marked a
period of aggressive internationalism & international
organization building & though health was not initially
thought to be under the U.N. After its motion started
by Brazilian & Chinese delegates to establish an
international health organization and that was
generally accepted. A group of health experts,
working on emergency relief in World War II were
charged with the task of drafting a constitution to
define the structure & mandate of the body that
would become known as the World Health
Organization (WHO).
5. • Finally, WHO’s constitution came into force on
7 th April 1948. This date celebrates every year
as “ WORLD HEALTH DAY” by all over world.
6. RESPONSIBILTY
•
Global Health Matters Shaping the Health
research agenda (schedule) Setting norms &
standards Articulating evidence based policy
option Providing technical support to countries
Monitoring & assessing health trends
7. ORGANISATION
• The Executive Board is composed of 32
members, technically qualified in the field of
health. Members are elected for three years .
The head is the Director-General who is
appointed by the Health Assembly on the
nomination of the Executive Board.
8. • WHO Member States are grouped into six
regions . Each region has a regional office .
Regional offices are in Africa, America, South-
east Asia, Europe, Eastern Mediterranean &
Western Pacific.
• The World Health Assembly is the supreme
decision-making body for WHO. It meets each
year in May at Geneva , and is attended by
delegations from all 192 Member States .
9. FUNCTIONS
•
To give worldwide guidance in the field of
health. To set global standards for health. To
cooperate with governments in strengthening
national health programs. To develop and
transfer appropriate health technology
information.
10. WHO Expert Committee?
• Is an official Advisory Body to Director-General
of WHO Governed though specific rules and
procedures ( Ref . WHO Manual ) Participation
in Expert Committee (EC) meetings: Members
("Expert") selected from WHO Panel of Experts
Technical advisers Observers : - international
organizations , - NGOs , - professional
associations…
11. Continued..
• Report of the WHO Expert Committee:
Summarizes discussion Gives recommendations
to WHO and Member States Also includes
newly adopted guidelines And is presented to
WHO Governing Bodies for final comments,
endorsement and implementation by Member
States
12. Examples of WHO Expert Committees ?
• WHO Expert Committee on Specifications for
Pharmaceutical Preparations WHO Expert
Committee on the Selection and Use of
Essential Medicines WHO Expert Committee on
Drug Dependence WHO Expert Committee on
Biological Standardization Joint FAO/WHO
Expert Committee on Food Additives ….
13. WHO consultation process working
•
Step 1. Preliminary consultation and drafting
Step 2. Draft guidelines Step 3. Circulation for
comments Step 4. Revision process ..........
(back to step 2 and 3 as often as needed)
WHO Expert Committee (EC) meeting if
guideline adopted, published in EC report as
Annex Recommendation to Member States for
implementation
14. WHO Partners
• National and regional authorities International
organizations (UNAIDS, UNFPA, UNICEF, World Bank,
WIPO, WTO, etc) International professional and other
associations, NGOs (including consumer associations,
MSF, industry: IFPMA-IGPA- WSMI, FIP, WMA, etc)
WHO Expert Panels (official nomination process)
Specialists from all areas, regulatory, university,
industry……… WHO Collaborating Centers (official
nomination process) Pharmacopoeia Commissions and
Secretariats, national institutions and institutes ..
Regional and inter- regional groups (ICH…)
15. WHO guidelines
•
WHO guidelines Covers guidelines for Stability
guidelines Sampling guidelines Production
Quality Control Distribution
16. WHO stability guidelines Title:
• “ guidelines for stability testing of
pharmaceutical products containing well
established drug substances in conventional
dosage forms ” It is for stability testing of final
drug products -> those are well established
(e.g. generics) & -> in conventional dosage
forms (e.g. tablets) Design of stability study
includes guidelines for: -> test samples -> test
conditions - accelerated studies - real time
studies ->frequency of testing & evaluation of
test results
17. WHO guidelines on sampling of
pharmaceuticals Contains :-
• Purpose of sampling Controls to be applied to
the sample Sampling operations and
precautions Storage and retension Sampling for
regulatory purposes Sampling plans for starting
materials, packaging materials and finished
products
18. WHO’s guidelines for production
•
Good Manufacturing Practices (GMP) ….. 1.
Main principles for pharmaceutical products 2.
… for starting materials, including active
pharmaceutical ingredients pharmaceutical
excipients 3. … for specific pharmaceutical
products: Sterile pharmaceutical products
Biological products Investigational
pharmaceutical products for clinical trials in
humans Herbal medicines
Radiopharmaceuticals
19. Continued..
• New additional GMP texts: 1. Main principles for
pharmaceutical products +++ requirement for
the sampling of starting materials (amendment)
water for pharmaceutical use heating,
ventilation and air-conditioning (HVAC) systems
Validation 3. … for specific pharmaceutical
products: +++ Herbal medicines (revised
20. WHO’s guidelines for quality control
• International specifications ( Int.Ph ., screening
tests..) WHO Model Certificate of Analysis
(COA) Considerations for requesting analysis of
samples Quality control laboratories: Good
practices for national control labs List of
equipment External qc assessment scheme for
labs
21. WHO’s guidelines for distribution
• WHO Certification Scheme for Products Moving
in International Commerce New scheme for
pharmaceutical starting materials: - model
certificate, when inspected by national
authority WHO model for self-assessment for
manufacture of pharmaceutical starting
materials Good Distribution and Trading
Practices for pharmaceutical starting materials
(GTDP) Good Distribution Practices (GDP) (for
products) Good Storage Practices (GSP)
22. AGENDA
•
1. Promoting development 2. Fostering health
security 3. Strengthening health systems 4.
Harnessing research, information & evidence 5.
Enhancing partnerships 6. Improving
performance
