WHO Expert Committee on Specification for Pharmaceutical Preparations [[electronic resource] ] : forty-second report

• Record Nr.: UNINA9910454491403321
• Pubbl/distr/stampa: Geneva, Switzerland, : World Health Organization, 2008
• ISBN: 1-281-74403-4; 9786611744038; 92-4-068310-0
• Descrizione fisica: 1 online resource (150 p.)
• Collana: WHO technical report series, , 0512-3054 ; ; 948
• Disciplina: 615.1; 615/.1
• Soggetti: Drugs - Standards; Pharmaceutical technology - Standards; Drugs - Law and legislation; Electronic books.
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: Preliminaries; Contents; 1 Introduction; 2 General policy; 3 Quality control specifications and tests; 4 Quality control International Chemical Reference Substances and International Infrared Reference Spectra; 5 Quality control national laboratories; 6 Quality assurance good manufacturing practices; 7 Quality assurance new approaches and risk analysis; 8 Quality assurance distribution and trade of pharmaceuticals; 9 Quality assurance stability; 10 Prequalification of priority essential medicines and devices; 11 Prequalification of active pharmaceutical ingredients; 12 Prequalification of quality control laboratories 13 Active pharmaceutical ingredient master file; 14 Regulatory guidance; 15 Nomenclature terminology and databases; 16 Miscellaneous; 17 Summary and recommendations; Acknowledgements; and International Infrared Reference Spectra; condoms for purchase by United Nations agencies; intrauterine devices for purchase by United Nations agencies; Guidelines on active pharmaceutical ingredient mas
• Sommario/riassunto: The Expert Committee on Specifications for Pharmaceutical ; Preparations works towards clear, independent and practical standards and guidelines for medicines' quality assurance. Standards are developed by the Committee through worldwide consultation and an international consensus building process. The forty-second meeting adopted 11 new monographs for inclusion in The International Pharmacopoeia (Ph.Int.) and seven related new International Chemical Reference Standards (ICRS). The specifications currently developed are internationally applicable test methodologies for antimalarial, antitubercul