Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2008-05-05 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards standards and guidelines for medicines' quality assurance. 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 Program, 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.--Publisher's description.

Download or read book National Library of Medicine Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1972 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.

Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1968 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: Includes subject section, name section, and 1968-1970, technical reports.

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Download or read book Advice Concerning the Addition of Certain Pharmaceutical Products and Chemical Intermediates to the Pharmaceutical Appendix to the Harmonized Tariff Schedule of the United States Inv 332 476 written by and published by DIANE Publishing. This book was released on with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Cumulative List of Proposed International Nonproprietary Names for Pharmaceutical Substances written by and published by . This book was released on 1971 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2019-05-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 consensusbuilding process. The following new guidelines were adopted and recommended for use: Procedure for development of the WHO medicines quality assurance guidelines; Guidelines on Good Manufacturing Practices (GMP) for heating ventilation and air-conditioning systems (HVAC) ? illustrative part; Guidance on GMP for Validation including the general main text analytical procedure validation validation of computerized systems and qualification; in the area of interchangeability of multisource medicines: the Protocol to conduct equilibrium solubility experiments for the purpose of biopharmaceutics classification systembased classification of active pharmaceutical ingredients for biowaiver; Guidelines on Import Procedures for pharmaceutical products; and the Good Practice Guidance document on implementing the collaborative procedures. All of the above are included in this report and recommended for implementation.

Download or read book Drug Literature written by United States. Congress. Senate. Committee on Government Operations. Subcommittee on Reorganization and Internal Organizations and published by . This book was released on 1963 with total page 194 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book National Library of Medicine Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1960 with total page 910 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Cumulative List of Proposed International Nonproprietary Names for Pharmaceutical Substances written by and published by . This book was released on 1971 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Drug Literature written by United States. Congress. Senate. Government Operations and published by . This book was released on 1953 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Drug Literature a Factual Survey on The Nature and Magnitude of Drug Literature written by National Library of Medicine (U.S.) and published by . This book was released on 1963 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.

Download or read book WHO Drug Information written by and published by World Health Organization. This book was released on 2022-01-28 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations and published by World Health Organization. This book was released on 2007 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting and published by World Health Organization. This book was released on 2016 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 6 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further acknowledged the progress of good pharmacopoeial practices (GPhP), and adopted the document on GPhP which was prepared by the 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 10 guidelines as listed below as well as 22 new specifications and general texts for inclusion in The International Pharmacopoeia. 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.