UID:
almahu_9949858762602882
Umfang:
1 online resource (430 pages)
Ausgabe:
1st ed.
ISBN:
9789240063822
Serie:
Technical Report Series - World Health Organization Series
Anmerkung:
Intro -- Contents -- Abbreviations -- WHO Expert Committee on Specifications for Pharmaceutical Preparations -- Declarations of interest -- OPEN SESSION -- Introduction and welcome -- I. ECSPP procedures and processes -- II. Update on new guidelines, norms and standards -- III. Technical agenda topics of the fifty-sixth ECSPP -- IV. Points of discussion -- PRIVATE AND CLOSED SESSIONS -- Opening -- Election of chairpersons and rapporteurs -- Participation in ECSPP meetings -- 1. General policy -- 1.1 Process for development of WHO norms and standards -- 2. General updates and matters for information -- 2.1 Expert Committee on Biological Standardization -- 2.2 Expert Committee on the Selection and Use of Essential Medicines -- 2.3 Prequalification of medicines -- 2.4 Member State Mechanism and post-market surveillance -- 2.5 International Conference of Drug Regulatory Authorities -- 3. Quality assurance: collaboration initiatives -- 3.1 International Meeting of World Pharmacopoeias -- 4. Nomenclature, terminology and databases -- 4.1 International nonproprietary names for pharmaceutical substances -- 4.2 Quality assurance terminology -- 4.3 Guidelines and guidance texts adopted by the ECSPP -- 5. Quality control: national laboratories -- 5.1 External Quality Assurance Assessment Scheme -- 5.1.1 Final report on EQAAS phase 10 -- 5.1.2 Update on EQAAS phase 11 -- 6. Quality control: specifications and tests -- 6.1 The International Pharmacopoeia -- 6.1.1 Workplan 2022-2023 -- 6.2 General chapters -- 6.2.1 Chromatography -- 6.3 Specifications and draft monographs for medicines, including paediatrics and candidate medicines for COVID-19 -- 6.3.1 COVID-19 therapeutics -- 6.3.2 Medicines for maternal, newborn, child and adolescent health -- 6.3.3 Antimalarial medicines -- 6.3.4 Antituberculosis medicines.
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6.3.5 Antiviral medicines, including antiretrovirals -- 6.3.6 Other medicines -- 6.4 Update on the virtual consultations on screening technologies, laboratory tools and pharmacopoeial specifications -- 7. Quality control: international reference materials -- 7.1 Update on International Chemical Reference Substances -- 8. Quality assurance: good manufacturing practices and inspection -- 8.1 Good manufacturing practices for sterile pharmaceutical products -- 8.2 Good manufacturing practices for investigational radiopharmaceutical products -- 8.3 Guidelines on technology transfer in pharmaceutical manufacturing -- 8.4 Good manufacturing practices for medicinal gases -- 8.5 Good practices for research and development facilities -- 8.6 Good manufacturing practices for investigational products -- 8.7 Recommendations from the virtual consultation on good practices for health products manufacture and inspection -- 9. Quality assurance: distribution and supply chain -- 9.1 Setting remaining shelf-life for supply and procurement of emergency health kits -- 9.2 WHO/UNFPA guidance on natural rubber latex condom stability studies -- 9.3 WHO/UNFPA technical specification for TCu380A intrauterine device -- 10. Regulatory guidance and model schemes -- 10.1 WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for medicines included in the EML -- 10.2 WHO guidance on registration requirements to establish interchangeability for multisource (generic) products -- 10.3 Update on WHO-listed authorities -- 10.4 WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce -- 10.5 Recommendations from the virtual consultation on regulatory guidance for multisource products -- 10.6 Ongoing activities and proposed new topics for regulatory guidance and model schemes -- 11. Miscellaneous: update on COVID-19 activities.
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11.1 Therapeutic specifications -- 11.2 Existing guidance -- 11.3 New activities -- 12. Closing remarks -- 13. Summary and recommendations -- 13.1 Guidelines and decisions adopted and recommended for use -- 13.2 Texts adopted for inclusion in The International Pharmacopoeia -- 13.2.1 General chapters -- 13.2.2 Monographs -- 13.2.3 International Chemical Reference Substances (ICRS) -- 13.3 Recommendations -- 13.3.1 The International Pharmacopoeia -- 13.3.2 Quality control: national laboratories -- 13.3.3 Good manufacturing practices and related areas -- 13.3.4 Distribution and supply chain -- 13.3.5 Regulatory mechanisms -- 13.3.6 Other -- Acknowledgements -- References -- Annex 1 -- Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations -- Annex 2 -- WHO good manufacturing practices for sterile pharmaceutical products -- Annex 3 -- IAEA/WHO guideline on good manufacturing practices for investigational radiopharmaceutical products -- Annex 4 -- WHO guidelines on technology transfer in pharmaceutical manufacturing -- Annex 5 -- WHO good manufacturing practices for medicinal gases -- Annex 6 -- WHO good practices for research and development facilities of pharmaceutical products -- Annex 7 -- WHO good manufacturing practices for investigational products -- Annex 8 -- Points to consider for setting the remaining shelf-life of medical products upon delivery -- Annex 9 -- WHO/UNFPA guidance on natural rubber latex male condom stability studies -- Annex 10 -- WHO/UNFPA technical specification for TCu380A intrauterine device -- Annex 11 -- WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms.
Weitere Ausg.:
Print version: WHO Expert Committee on Specifications for Pharmaceutical Preparations Geneva : World Health Organization,c2022
Sprache:
Englisch
Schlagwort(e):
Electronic books.
;
Electronic books.
URL:
Click here to view book
