Transcript Safe quality medicines 1 Technical Briefing Seminar | 1 November 2012 Medicines quality assurance: WHO's normative functions in the field of pharmaceuticals Sabine Kopp, PhD Quality.

Safe quality
medicines
1 Technical Briefing Seminar | 1 November 2012
Medicines quality assurance:
WHO's normative functions in
the field of pharmaceuticals
Sabine Kopp, PhD
Quality Assurance and Safety: Medicines
Department of Essential Medicines and Health Products
Main points addressed
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Who is WHO?
How does WHO set standards?
Which WHO guidelines,
standards and norms exist in
the area of quality assurance?
What's new ?
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Who is WHO? Governing bodies
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World Health Assembly (WHA)
Delegations from 194 Member States
Meeting yearly in May
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Executive Board (EB)
Representatives from 34 Member States +
Meeting biannually in January and May
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Impressions from World Health Assembly
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- SSFFC
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WHO is WHO ? Secretariat and Experts
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WHO Secretariat:
- Headquarters
- six Regional Offices and 149 Country offices
Experts:
- WHO Expert Panels and Expert Committees
- WHO Collaborating Centres
- + partners
Constitution signed 1946, in force since 7 April 1948
(World Health Day)
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WHO Governing bodies …
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What is the WHO Expert Committee?
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Official Advisory Body to Director-General of WHO
Governed though 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…
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WHO Expert Committees rules and procedures
 WHO Basic Documents
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Constitution of WHO
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Expert Committees:
chapter V, article 18; chapter VIII, articles 38-40
For normative function - pharmaceuticals:
Chapter 2, article 2 (u): " to develop, establish and promote
international standards with respect to food, biological, pharmaceutical
and similar products;"
Regulations for Expert Advisory Panels and
Committees, including, Annex – Rules of Procedure for Expert
Committees
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Examples of WHO Expert Committees ?
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WHO Expert Committee on Specifications for
Pharmaceutical Preparations
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WHO Expert Committee on the Selection and Use of
Essential Medicines
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WHO Expert Committee on Drug Dependence
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WHO Expert Committee on Biological Standardization
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Joint FAO/WHO Expert Committee on Food Additives
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….
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Outcome of the WHO Expert Committee?
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Report of the WHO Expert Committee:
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Summarizes discussion
Gives recommendations to WHO + Member States
Includes newly adopted guidelines;
Is presented to WHO Governing Bodies for final
comments, endorsement and implementation by
Member States
 constitutes
WHO technical guidance
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When does the WHO Expert Committee
start development of a guideline/guidance?
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Based on recommendations by :
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World Health Assembly resolutions (e.g. WHA 20.34, GMP - Good
manufacturing practices)
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Executive Board resolutions (e.g. EB37.R9 delegating certain functions of
INN Programme to DG based on advice from Experts)
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International Conference of Drug Regulatory Authorities (e.g.
10th +11th ICDRA – FDC guidelines + Certification Scheme for pharmaceutical
starting materials moving into international commerce)
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Other WHO programmes and clusters (e.g. necessity for quality control
specifications for specific medicines of major public health interest and feedback
from Prequlifcation programme)
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Expert Committee (e.g. revision of general methods included in The
International Pharmacopoeia)
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How does the WHO consultation process
work?
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Step 1. Preliminary consultation and drafting
Step 2. Draft guidelines
Step 3. Circulation for comments
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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
-> WHO Governing bodies
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-> Recommendation to Member States for implementation
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WHO Partners
With Regulatory Bodies…
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National/Regional regulatory authorities
Regional/Interregional regulatory groups (ASEAN, GCC, ICH,
PANDRH...)
Within WHO…
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WHO disease programmes (Stop TB, Roll-Back Malaria,
HIV/AIDS, Tropical Neglected Diseases, programmes on
Children, Women's Health… )
Prequalification Programme – A United Nations Programme
managed by WHO
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WHO Partners (2)
With Organizations and Associations…
 International organizations (UNAIDS, UNICEF, IAEA,
Global Fund, World Bank…)
 International professional and other associations, NGOs
(incl. industry, consumer associations: IFPMA, IGPA,
WSMI, IPEC, FIP, WMA, MSF…)
With Standard-setting Bodies, such as …
 Pharmacopoeia Commissions and Secretariats (e.g.
British Brazilian, Chinese, European, Indian, Korean,
Japanese, USP, .. )
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WHO Partners (3)
With "recognized" Experts…
 WHO Expert Panel on The International Pharmacopoeia and
Pharmaceutical Preparations (official nomination process)
 Specialists from all areas for specific projects (regulatory,
university, industry…)
With "recognized" Laboratories…
 National/Regional Quality control laboratories
 WHO Collaborating Centres (official nomination process)
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Medicines Quality Assurance in WHO
Historical overview
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1st "WHO Expert Committee on Specifications
for Pharmaceutical Preparations" ( ECSPP)
meeting held 13-17 October 1947
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Report of 1st ECSPP meeting published in:
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Official Records of WHO, No 8, page
54ff, 1947
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WHO’s medicines quality assurance
guidelines
Cover:
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Development
Production
Quality Control
Quality related regulatory guidelines
Inspection
Distribution
 from manufacture (and before) to delivery to
patient
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Adopted WHO guidance texts and guidelines
in medicines quality assurance (without PhInt)
Maintain to keep up to date:
 More
than 60 CURRENT official WHO
guidance texts and guidelines to date;
 8 updates + 7 new adopted 2010;
 2 updates + 4 new adopted 2011;
 2 updates + 2 new adopted 2012.
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Quality Control
http://www.who.int/medicines/areas/quality_safety/quality_assurance/contr
ol/
More than 10 guidance documents and guidelines,
including
- Good laboratory practices + training materials
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Guidelines for establishment of chemical reference
standards
Model certificate of analysis
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International Pharmacopoeia + Basic tests
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International Pharmacopoeia
Ph.Int.
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current: 4th edition! Supplement 1 +2
implementation: “ready for use” by Member States
Scope since 1975:
 Model List of Essential Medicines and
 Drugs recommended by WHO Specific disease
programmes, e.g. Malaria, TB, HIV/AIDS,
medicines for children
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Distribution
http://www.who.int/medicines/areas/quality_safety/quality_ass
urance/distribution
Some 10 guidance documents and guidelines, e.g.:
- Certification schemes (CPP and SMACS)
- Quality system for Procurement
- Good distribution practices for starting materials and finished
products
- Good storage practices
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Production
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http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/
Some 20 guidance documents and guidelines, including:
- Good Manufacturing Practices (GMP)
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…..Consisting of more than 10 major "guideline" texts
(regularly updated, new texts added as needs are
identified)
….. Training materials (slides, video, GMP text)
Risk analysis (HACCP) – moving to "quality risk
management"
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Quality related regulatory
standards
http://www.who.int/medicines/areas/quality_safety/quality_assurance/re
gulatory_standards/
Some 20 guidance documents and guidelines, including :
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Stability testing requirements
Interchangeability of generic medicines
Fixed-dose combination
All prequalification procedures
24 Technical Briefing Seminar | 1 November 2012
47th WHO Expert Committee on Specifications for
Pharmaceutical Preparations – outcome - 1-
1. Adopted texts: The International Pharmacopoeia
Monographs for the following:
- Medicines for HIV and related conditions
- Antimalarial medicines
- Antituberculosis medicines
- Anti-infectives
Harmonized general texts (based on PDG texts)
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47th WHO Expert Committee on Specifications for
Pharmaceutical Preparations – outcome -2-
2. Adopted global quality assurance guidelines:
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New guidance on quality risk management (QRM)
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Guidance on variations to a prequalified product (revision)
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Collaborative procedure between WHO PQ and NMRAs in
the assessment and accelerated registration of national
WHO-prequalified pharmaceutical products
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46th WHO Expert Committee on Specifications for
Pharmaceutical Preparations – outcome -3-
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Quality requirements of artemisinin as a starting
material in the production of antimalarial active
pharmaceutical ingredients
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Advantages of WHO's Expert Committee
standard-setting process
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1. Guidelines and specifications validated
internationally, through an independent scientific
process, adoption by members of WHO Expert
Advisory Panels
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2. Collaboration with standard-setting organizations
and parties, including regional and national
pharmacopoeias
3. Networking and close collaboration with WHO
Member States, Drug Regulatory Authorities, national
medicines quality control laboratories
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Advantages of WHO's Expert Committee
standard-setting process (2)
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4. Links with other WHO activities
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5. Reality check: Input from manufacturers
(including international associations of research,
generic and self-medication associations) around
the world
6. Consideration of costs, e.g. keeping need for
reference standards at a minimum
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7. Service FREE FOR USE by all Member States
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WHO Medicines Quality Assurance website:
http://www.who.int/medicines/areas/quality_safety/quality_assurance
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Safe quality
medicines
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