WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-second Report.
Title:
WHO Expert Committee on Specifications for Pharmaceutical Preparations : Forty-second Report.
Author:
WHO.
ISBN:
9789240683105
Personal Author:
Physical Description:
1 online resource (150 pages)
Series:
Technical Report Series, No. 948 ; v.948
Technical Report Series, No. 948
Contents:
Technical Report Series: WHO Expert Committee on Specifications for Pharmaceutical Preparations- 42nd report -- Contents -- Introduction -- General policy -- Collaboration with international organizations and agencies -- Cross-cutting pharmaceuticals - quality assurance issues -- Essential medicines for children -- Counterfeit medicines -- Quality control-specifications and tests -- The International Pharmacopoeia -- Proposed new work plan -- Specifi cations for medicines, including children's medicines -- Revision of texts -- General monographs for dosage forms and associated method texts -- Radiopharmaceuticals -- Dissolution tests for addition to specifi c monographs -- Quality control - International Chemical Reference Substances and International Infrared Reference Spectra -- Annual report of the WHO Collaborating Centre -- Adoption of new International Chemical Reference Substances -- Infrared Reference Spectra -- Quality control - national laboratories -- External Quality Assurance Assessment Scheme -- Quality assurance - good manufacturing practices -- Good manufacturing practices for active pharmaceutical ingredients -- Good manufacturing practices for biologicals -- Good manufacturing practices - new texts -- Quality assurance - new approaches and risk analysis -- Technology transfer -- Quality assurance - distribution and trade of pharmaceuticals -- WHO Certification Scheme -- Quality assurance - stability -- Prequalification of priority essential medicines and devices -- Procedure for prequalification of medicines -- Procedures for prequalification of intrauterine devices and condoms -- Prequalifi cation of active pharmaceutical ingredients -- Procedure for prequalification of active pharmaceutical ingredients -- Prequalification of quality control laboratories -- Active pharmaceutical ingredient master file -- Regulatory guidance.
Specific guidance on children's medicines -- Guidelines for pharmaceutical development of generics -- Quality of herbal and complementary medicines -- Near infrared spectroscopy -- Nomenclature, terminology and databases -- WHO terminology used in quality assurance -- International Nonproprietary Names for pharmaceutical substances -- Pharmacopoeial references -- Miscellaneous -- Diethylene glycol -- Regulatory burden - inspections -- Summary and recommendations -- Acknowledgements -- Annex 1: List of available International Chemical Reference Substances and International Infrared Reference Spectra -- International Chemical Reference Substances -- List of available International Infrared Reference Spectra -- Annex 2: Procedure for assessing the acceptability,in principle, of male latex condoms for purchase by United Nations agencies -- Introduction -- The prequalification scheme for male latex condoms -- Confidentiality undertaking -- Conflict of interest -- Appendix - List of standards and specifi cations -- Annex 3: Procedure for assessing the acceptability, in principle, of TCu380A intrauterine devicesfor purchase by United Nations agencies -- Introduction -- The prequalification scheme for TCu380A intrauterine devices -- Confidentiality undertaking -- Conflict of interest -- Appendix - List of standards and specifications -- Annex 4: Guidelines on active pharmaceutical ingredient master file procedure -- Introduction -- Scope -- Content of the active pharmaceutical ingredient master file -- Use of the APIMF procedure -- Steps of the APIMF procedure -- Content of the product dossier when the APIMF procedure is used -- Changes and updates to the APIMF -- Appendix 1 - Template letter of access -- Appendix 2 - Part of covering letter -- Annex 5: International Nonproprietary Names for biological and biotechnological substances -- Introduction.
Pharmacological classification of biological and biotechnological substances -- Current status of existing stems or systems -- General policies for biological and biotechnological substances -- Summary of INN assigned to biological and biotechnological substances -- Current challenges.
Abstract:
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, antituberculosis, antiretroviral and specifically also medicines for children. The main principles for selection of INNs for biologicals were endorsed. In order to serve the WHO-managed Prequalification Programme, two new procedures were adopted, namely on prequalification of intrauterine devices (IUDs) and of male latex condoms, together with a new guidance on the assessment of active pharmaceutical ingredients for use in medicines. The international guidelines, specifications and nomenclature developed under the aegis of the Expert Committee on Specifications for Pharmaceutical Preparations serve all Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, and underpin important initiatives, including the prequalification of medicines, the Roll Back Malaria Programme, Stop TB, essential medicines and medicines for children. The advice and recommendations provided by this Expert Committee are intended to help national and regional authorities (in particular DRAs), procurement agencies, as well as major international bodies and institutions, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and international organizations such as the United Nations Children's Fund (UNICEF) to combat problems of
counterfeit and substandard medicines and to fill the gap for medicines used in the treatment of large populations, for which no international quality requirements are publicly available. WHO through this Expert Committee and with the help of many Member States' direct and indirect contributions, develops independent international standards through worldwide consultation and an international consensus building process. These are free for use and are developed by WHO with no commercial interest. Special efforts are made to keep their implementation costs low, but without compromising the quality, for example by reducing the number of physical reference standards needed for a Ph.Int. monograph to a minimum. These independent quality standards and guidelines will enable Member States and other parties to meet the challenges created by increasing globalization and to help ensure that all, including poor patient populations will receive quality medicines.
Local Note:
Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2017. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.
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