WHO Expert Committee on Specifications for Pharmaceutical Preparations's Books

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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374

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World Health Organization

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ISBN 10

9241209968

ISBN 13

9789241209960

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-ninthReport

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-ninthReport

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting

The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs general texts and ICRS. It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP) and was informed of progress achieved with developing a comprehensive document on GPhP through discussions at consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP) distribution and trade of pharmaceuticals and regulatory practice. It adopted eight guidelines and 16 technical supplements as listed below including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project. The report includes the following annexes which are recommended as new WHO guidelines: . Annex 1. Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision); . Annex 2. Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia (revision); . Annex 3. Supplementary guidelines on good manufacturing practices: validation; Appendix 7: non-sterile process validation (revision); . Annex 4. General guidance for inspectors on hold-time studies (new); . Annex 6. Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision); . Annex 7. Guidelines on registration requirements to establish interchangeability (revision); . Annex 8. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision); . Annex 9: Good review practices guidelines for regulatory authorities (new). In addition 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were adopted for publication in a format which is appropriate to the large volume of this guidance (Annex 5). The newly adopted monographs were adopted for inclusion in The International Pharmacopoeia. Following the implementation of the revised general monograph on parenteral preparations the Committee adopted the proposed endotoxin limits for 11 parenteral dosage form monographs lacking such specification together with related updates to relevant monographs. The Committee adopted 12 ICRS newly characterized by the custodian centre EDQM. The Committee further adopted the workplan for new monographs to be included in The International Pharmacopoeia.

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224

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World Health Organization

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ISBN 10

9241209925

ISBN 13

9789241209922

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-eighth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-eighth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.

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Page Count

401

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World Health Organization

Published Date

ISBN 10

9241209860

ISBN 13

9789241209861

Who Expert Committee on Specifications for Pharmaceutical Preparations

Forty-seventh Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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Who Expert Committee on Specifications for Pharmaceutical Preparations

Forty-seventh Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

WHO's international guidelines, written and physical standards developed under the aegis of this Expert Committee for more than 60 years are designed to 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 Forty-seventh WHO Expert Committee on Specifications for Pharmaceutical Preparations adopted 26 new monographs and general texts for inclusion in The International Pharmacopoeia,/I>. The specifications under development are internationally applicable test methodologies for anti-infective, antimalarial, antituberculosis, contraceptives and antiretroviral medicines, as well as medicines for children. In addition, the following four written standards were adopted in the area of quality assurance and are now available for implementation : * Release procedure for International Chemical Reference Substances (update); * WHO guideline on quality risk management (new) * WHO guideline on variations to a prequalified product (update) * Collaborative procedure between the WHO Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products (new).

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Page Count

188

Published Date

ISBN 10

924120981X

ISBN 13

9789241209816

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-first Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-first Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

This report sets out the recommendations of an international group of experts relating to developments in the quality assurance of medicines and specifications for drug substances and dosage forms. It contains guidelines of direct relevance to the UN Prequalification Programme for Priority Essential Medicines and for quality control laboratories, including procedures governing the assessment of pharmaceutical products for procurement by UN agencies and for assessing the acceptability of quality control laboratories. It also includes discussion regarding several monographs for inclusion in the International Pharmacopoeia, relating to antiretrovirals, including fixed-dose combinations, TB medicines and antimalarial and paediatric medicines.

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Page Count

173

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World Health Organization

Published Date

ISBN 10

9241209437

ISBN 13

9789241209434

WHO Expert Committee on Specifications for Pharmaceutical Preparations

By: World Health Organization Staff

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

By: World Health Organization Staff

WHO Expert Committee on Specifications for Pharmaceutical Preparations, ....

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208

Published Date

ISBN 10

924120902X

ISBN 13

9789241209021

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-first Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-first Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations,World Health Organization

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173

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World Health Organization

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ISBN 10

9241209437

ISBN 13

9789241209434

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Fiftieth Report

By: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting,World Health Organization

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374

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World Health Organization

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ISBN 10

9241209968

ISBN 13

9789241209960

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-second Report

By: Comité OMS d'experts des spécifications relatives aux préparations pharmaceutiques,WHO.,World Health Organization

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WHO Expert Committee on Specifications for Pharmaceutical Preparations

Forty-second Report

By: Comité OMS d'experts des spécifications relatives aux préparations pharmaceutiques,WHO.,World Health Organization

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.

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Page Count

150

Published Date

ISBN 10

9240683100

ISBN 13

9789240683105

WHO Expert Committee on Biological Standardization

Sixty-first Report

By: WHO Expert Committee on Biological Standardization. Meeting,World Health Organization. Expert Committee on Biological Standardization

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WHO Expert Committee on Biological Standardization

Sixty-first Report

By: WHO Expert Committee on Biological Standardization. Meeting,World Health Organization. Expert Committee on Biological Standardization

The WHO Expert Committee on Biological Standardization (ECBS) met in Geneva from 18 to 22 October 2010"--Introduction.

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Page Count

398

Publisher

World Health Organization

Published Date

ISBN 10

924120978X

ISBN 13

9789241209786

Book's by WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

Who Expert Committee on Specifications for Pharmaceutical Preparations

Who Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Biological Standardization

WHO Expert Committee on Biological Standardization

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