1 Technical Briefing Seminar | 1 November 2012 Safe quality medicines.

1 Technical Briefing Seminar | 1 November 2012

Safe quality medicines

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

Who is WHO? How does WHO set standards? Which WHO guidelines,

standards and norms exist in the area of quality assurance?

What's new ?


Who is WHO? Governing bodies

World Health Assembly (WHA) Delegations from 194 Member States Meeting yearly in May

Executive Board (EB)Representatives from 34 Member States +Meeting biannually in January and May


Impressions from World Health Assembly

- SSFFC


WHO is WHO ? Secretariat and Experts

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)


WHO Governing bodies …


What is the WHO Expert Committee?

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…


WHO Expert Committees rules and procedures

WHO Basic Documents

Constitution of WHO 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


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 ….


Outcome of the WHO Expert Committee?

Report of the WHO Expert Committee:

- 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


When does the WHO Expert Committee start development of a guideline/guidance?

Based on recommendations by :

World Health Assembly resolutions (e.g. WHA 20.34, GMP - Good manufacturing practices)

Executive Board resolutions (e.g. EB37.R9 delegating certain functions of INN Programme to DG based on advice from Experts)

International Conference of Drug Regulatory Authorities (e.g. 10th +11th ICDRA – FDC guidelines + Certification Scheme for pharmaceutical starting materials moving into international commerce)

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)

Expert Committee (e.g. revision of general methods included in The International Pharmacopoeia)


How does the WHO consultation process work?

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 -> WHO Governing bodies -> Recommendation to Member States for implementation


WHO Partners

With Regulatory Bodies… National/Regional regulatory authorities Regional/Interregional regulatory groups (ASEAN, GCC, ICH,

PANDRH...)

Within WHO… 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


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, .. )


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)


Medicines Quality Assurance in WHO

Historical overview

1st "WHO Expert Committee on Specifications for Pharmaceutical Preparations" ( ECSPP) meeting held 13-17 October 1947

Report of 1st ECSPP meeting published in:

Official Records of WHO, No 8, page 54ff, 1947


WHO’s medicines quality assurance guidelines

Cover: Development Production Quality Control Quality related regulatory guidelines Inspection Distribution from manufacture (and before) to delivery to

patient


Adopted WHO guidance texts and guidelinesin 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.


Quality Control

http://www.who.int/medicines/areas/quality_safety/quality_assurance/control/

More than 10 guidance documents and guidelines, including

- Good laboratory practices + training materials- Guidelines for establishment of chemical reference

standards- Model certificate of analysis- International Pharmacopoeia + Basic tests


International PharmacopoeiaPh.Int.

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


Distribution

http://www.who.int/medicines/areas/quality_safety/quality_assurance/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


Production

- http://www.who.int/medicines/areas/quality_safety/quality_assurance/production/

Some 20 guidance documents and guidelines, including: - Good Manufacturing Practices (GMP)

…..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"


Quality related regulatory standards

http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/

Some 20 guidance documents and guidelines, including : - Stability testing requirements - Interchangeability of generic medicines- Fixed-dose combination- All prequalification procedures


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)

-


47th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -2-

2. Adopted global quality assurance guidelines:

New guidance on quality risk management (QRM)

Guidance on variations to a prequalified product (revision)

Collaborative procedure between WHO PQ and NMRAs in the assessment and accelerated registration of national WHO-prequalified pharmaceutical products


46th WHO Expert Committee on Specifications for Pharmaceutical Preparations – outcome -3-

Quality requirements of artemisinin as a starting material in the production of antimalarial active pharmaceutical ingredients


Advantages of WHO's Expert Committee standard-setting process

1. Guidelines and specifications validated internationally, through an independent scientific process, adoption by members of WHO Expert Advisory Panels

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


Advantages of WHO's Expert Committee standard-setting process (2)

4. Links with other WHO activities

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

7. Service FREE FOR USE by all Member States


WHO Medicines Quality Assurance website:

http://www.who.int/medicines/areas/quality_safety/quality_assurance


Safe quality medicines

1 Technical Briefing Seminar | 1 November 2012 Safe quality medicines.

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Transcript of 1 Technical Briefing Seminar | 1 November 2012 Safe quality medicines.