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WHO Prepared by, Guided by, Darshan Jethva Ms.Hina Bagada Roll no :-37 Assitant professor M.pharm (Q.A) Saurashtra University DEPARTMENT OF PHARMACEUTICAL SCIENCE SAURASHTRA UNIVERSITY RAJKOT


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. 5/12/2013 2


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. 5/12/2013 3

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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). 5/12/2013 4

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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. 5/12/2013 5


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 5/12/2013 6


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. 5/12/2013 7

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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. 5/12/2013 8

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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 . 5/12/2013 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. 5/12/2013 10

WHO Expert Committee?:

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 ?:

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:

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:

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:

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:

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:

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 :

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’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 5/12/2013 23


References http://en.wikipedia.org/wiki/World_Health_Organization www.who.int 5/12/2013 24

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THANK YOU 5/12/2013 25

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