WORLD HEALTH ORGANIZATION

-ASHOK KUMAR,
GROUP 20.

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

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 coordinate policy & practice around
quarantine & disease management. The
League of Nations established a health
organization in 1920 having also regional
bodies

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).

 Finally, WHOs constitution came into

force on 7 th April 1948. This date
celebrates every year as WORLD
HEALTH DAY by all over world.

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

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.

 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 .

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.

WHO Expert Committee?

Is an official Advisory Body to DirectorGeneral 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

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

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 .

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

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 interregional groups (ICH)

WHO guidelines

WHO guidelines Covers guidelines for

Stability guidelines Sampling guidelines
Production Quality Control Distribution

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

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

WHOs 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

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

WHOs 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

WHOs 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)

AGENDA

1. Promoting development 2. Fostering

health security 3. Strengthening health
systems 4. Harnessing research,
information & evidence 5. Enhancing
partnerships 6. Improving performance

WHO

 THANK YOU..