| Who Expert Committee on Specifications for Pharmaceutical Preparations: Fifty-Third Report Contributor(s): World Health Organization (Author) |
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ISBN: 9241210281 ISBN-13: 9789241210287 Publisher: World Health Organization OUR PRICE: $57.00 Product Type: Paperback - Other Formats Published: May 2019 |
| Additional Information |
| BISAC Categories: - Medical | Aids & Hiv - Medical | Drug Guides - Medical | Pharmacology |
| Dewey: 615.1 |
| Physical Information: 299 pages |
| Themes: - Topical - AIDS |
| Descriptions, Reviews, Etc. |
| Publisher 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 consensus-building 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. |
Contributor Bio(s): World Health Organization: - World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends. |