WHO Expert Committee on Specifications for Pharmaceutical Preparations PDF Download
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Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241210281
Category : Business & Economics
Languages : en
Pages : 303
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Book Description
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241210281
Category : Business & Economics
Languages : en
Pages : 303
Get Book Here
Book Description
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.
Author:
Publisher: World Health Organization
ISBN: 924002090X
Category : Medical
Languages : en
Pages : 324
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Book Description
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations; Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation; Good manufacturing practices: water for pharmaceutical use; Guideline on data integrity; WHO/United Nations Population Fund recommendations for condom storage and shipping temperatures; WHO/United Nations Population Fund guidance on testing of male latex condoms; WHO/United Nations Population Fund guidance on conducting post-market surveillance of condoms; WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce; Good reliance practices in the regulation of medical products: high-level principles and considerations; and Good regulatory practices in the regulations of medical products. All of the above are included in this report and recommended for implementation.
Author: C. Pierce Salguero
Publisher: ReadHowYouWant.com
ISBN: 1458787745
Category : Gardening
Languages : en
Pages : 314
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Book Description
This practical guide to the traditional herbalism of Thailand contains an overview of the history, theory, and spirituality of traditional Thai medicine, with a focus on the application to modern Western life....
Author: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Meeting
Publisher: World Health Organization
ISBN: 9241209968
Category : Medical
Languages : en
Pages : 374
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Book Description
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.
Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241515430
Category : Business & Economics
Languages : en
Pages : 228
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Book Description
This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and finally the country profiles. Apart from the section on practices and practitioners the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners which covers providers education and health insurance is a new section incorporated to reflect the emerging trends in T&CM and to gather new information regarding these topics at a national level. All new information received has been incorporated into individual country profiles and data graphs. The report captures the three phases of progress made by Member States; that is before and after the first WHO Traditional Medicine Strategy (1999?2005) from the first global survey to the second global survey (2005?2012) and from the second survey to the most recent timeline (2012?2018).
Author: Drug Committee and the Food and Drug Administration of Thailand
Publisher:
ISBN: 9789747549751
Category :
Languages : en
Pages :
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Book Description
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 444
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Book Description
Author:
Publisher:
ISBN: 9786161143725
Category :
Languages : en
Pages :
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Book Description
Author: Kurt Reynertson
Publisher: CRC Press
ISBN: 1466598425
Category : Health & Fitness
Languages : en
Pages : 326
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Book Description
The international trade in plants is growing steadily as the worldwide demand for natural and botanical raw materials increases. Customers value natural products and botanicals as "green" alternatives-safer ingredients for their families which also represent an environmentally and socially responsible choice for the planet. In order to build assura
Author: Lisa Offringa
Publisher: Springer
ISBN: 3319102419
Category : Science
Languages : en
Pages : 94
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Book Description
This book provides a description of cognitive impairment in the elderly population through the lens of Thai Traditional Medicine as it is practiced in northern Thailand. It provides an overview of Thai Traditional Medicine and the memory loss presented in elderly dementia. Some medicinal plants used by traditional Thai healers to treat cognitive decline and memory issues in the elderly are reviewed. Medicinal Plants of Northern Thailand for the Treatment of Cognitive Impairment in the Elderly provides readers with the detailed description of the in vitro screening of ten plants and those results. The bioactivity of these single plants exemplifies the success of using an ethnobotanical filter to identify plants with cognitive enhancing activity.
