[e-drug signale la parution du 40ème Rapport d'Expets sur les préparations
pharmaceutiques disponible seuleument en anglais à cette adresse
http://whqlibdoc.who.int/trs/who_TRS_937_eng.pdf 478 pages]
E-DRUG: 40th WHO Expert report pharmaceutical preparations
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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