[e-med] OMS: 40e rapport d'expert sur les preparations pharmaceutiques

["ReMeD" <remed@remed.org>]

Bonjour à tous, 

Le 40e rapport d'expert de l'OMS sur les spécifications pour les préparations pharmaceutiques est accessible gratuitement en ligne à l'adresse : http://whqlibdoc.who.int/trs/who_TRS_937_eng.pdf

Ci-dessous le détail des annexes et de la table des matières.



************************************************************

Date: Fri, 4 Aug 2006 09:53:35 +0200
[e-drug] 40th WHO Expert report pharmaceutical preparations

E-DRUG: 40th WHO Expert report pharmaceutical preparations
----------------------------------------------------------

Dear E-druggers,

The 40th edition of the WHO expert committee on specifications for pharmaceutical preparations (TRS 937) is available (for free!) online at http://whqlibdoc.who.int/trs/who_TRS_937_eng.pdf

It contains several interesting documents in the annexes:

Annex 1
List of available International Chemical Reference Substances and International Infrared Reference Spectra

Annex 2
Supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms

Annex 3
Supplementary guidelines on good manufacturing practices for the manufacture of herbal medicines

Annex 4
Supplementary guidelines on good manufacturing practices: validation

Annex 5
Good distribution practices for pharmaceutical products

Annex 6
A model quality assurance system for procurement agencies (Recommendations for quality assurance systems focusing on prequalifi cation of products and manufacturers, purchasing, storage and distribution of pharmaceutical products)

Annex 7
Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability

Annex 8
Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms

Annex 9
Additional guidance for organizations performing in vivo bioequivalence studies

The general text contains:


2. General Policy
2.1 Cross-cutting pharmaceuticals - quality assurance issues
2.1.1 Quality assurance
2.1.2 Policy, Access and Rational Use
2.1.3 Malaria
2.1.4 Biologicals/Vaccines
2.1.5 Production of oral rehydration salts
2.1.6 Other clusters and departments
2.1.7 International collaboration
2.1.8 Follow-up report to the Expert Committee
2.2 Pharmacopoeial Discussion Group
2.3 International Conference on Harmonisation
2.4 International Conference of Drug Regulatory Authorities
2.5 Counterfeit drugs
3. Quality control - specifi cations and tests
3.1 The International Pharmacopoeia (Fourth Edition)
3.1.1 Dissolution test requirements
3.2 Pharmacopoeial monographs on antiretrovirals
3.3 Quality specifi cations for antimalarials
3.4 Quality specifi cations for antituberculosis drugs
3.5 Specifi cations for other medicines
3.5.1 Revision of published monograph on oral rehydration
3.5.2 Monograph on oral powders
3.5.3 Monographs for excipients
3.5.4 Specifi cations on herbal medicines
3.6 Basic and screening tests
4. Quality control - International Reference Materials
4.1 International Chemical Reference Substances
4.2 New International Chemical Reference Substances for antiretrovirals
4.3 Guidelines for secondary reference substances 5. Quality control - national laboratories
5.1 External quality assurance assessment scheme 6. Quality assurance - Good Manufacturing Practices
6.1 Heating, ventilation and air-conditioning
6.2 Manufacture of herbal medicines
6.3 Validation
7. Quality assurance - inspection 11
7.1 Training modules for inspectors 11
8. Quality assurance - distribution 11
8.1 Good distribution practices for pharmaceutical products 11 9. Quality assurance - risk analysis 11
9.1 New approach to inspections and manufacture 11 10. Quality assurance - stability 12
10.1 Stability testing conditions 12
11. Prequalifi cation 12
11.1 Prequalifi cation of priority medicines 12
11.2 Quality assurance for assessment of procurement agencies - Model Quality Assurance System 13
11.3 Prequalifi cation of quality control laboratories 13
11.4 Procedure for prequalifi cation - manufacturers of active pharmaceutical ingredients 13 12. Regulatory guidance on interchangeability for multisource (generic) pharmaceutical products 13
12.1 Guidelines on registration requirements to establish interchangeability 13
12.2 Revision/update of the guidance on the selection of comparator pharmaceutical products for equivalence assessment 14
12.3 List of comparator products for prequalifi cation 14
12.4 Proposal to waive in vivo bioequivalence requirements for the WHO Model List of Essential Medicines, immediate release, solid oral dosage forms 14
12.5 Additional guidelines for organizations performing in vivo bioequivalence studies 14 13. Donations of medicines 15
13.1 Quality of medicines donated (directly from the manufacturer) 15 14. Regulatory guidance on post-approval changes 15
14.1 Guidance on variations to a prequalifi ed dossier 15 15. Nomenclature and computerized systems 15
15.1 International Nonproprietary Names 15
15.2 WHO nomenclature used in quality assurance 16 16. Summary and recommendations 16
16.1 New standards and guidelines adopted and recommended for use 17
16.2 Activities that should be pursued and progress reported at the next meeting of the Expert Committee 18
16.3 New areas of work suggested 19