| 000 | 00000nam u2200205 a 4500 | |
| 001 | 000045878240 | |
| 005 | 20240816174922 | |
| 008 | 160805s2016 000 0 eng d | |
| 020 | ▼a 9789241209960 | |
| 040 | ▼a 211009 ▼c 211009 ▼d 211009 | |
| 082 | 0 4 | ▼a 610.8 ▼2 22 |
| 090 | ▼a 610.8 ▼b t ▼c 996 | |
| 245 | 1 0 | ▼a WHO Expert Committee on Specifications for Pharmaceutical Preparations : ▼b fiftieth report / ▼c WHO Expert Committee on Specifications for Pharmaceutical Preparations. |
| 260 | ▼a Geneva : ▼b World Health Organization, ▼c 2016. | |
| 300 | ▼a 358 pages : ▼b ill ; ▼c 24 cm. | |
| 490 | 1 | ▼a WHO technical report series, ▼x 0512-3054 ; ▼v 996 |
| 650 | 1 2 | ▼a Pharmaceutical Preparations ▼x standards ▼v Congresses. |
| 650 | 1 2 | ▼a Technology, Pharmaceutical ▼x standards ▼v Congresses. |
| 650 | 1 2 | ▼a Drug Industry ▼x legislation & jurisprudence ▼v Congresses. |
| 650 | 0 | ▼a Drugs ▼x Standards ▼v Congresses. |
| 650 | 0 | ▼a Drugs ▼x Specifications ▼v Congresses. |
| 650 | 0 | ▼a Drugs ▼x Quality control ▼v Congresses. |
| 710 | 2 | ▼a WHO ▼0 AUTH(211009)64026. |
| 710 | 2 | ▼a World Health Organization. |
| 830 | 0 | ▼a Technical report series (World Health Organization) ; ▼v 986. |
Holdings Information
| No. | Location | Call Number | Accession No. | Availability | Due Date | Make a Reservation | Service |
|---|---|---|---|---|---|---|---|
| No. 1 | Location Centennial Digital Library/UN/ | Call Number 610.8 t 996 | Accession No. 181009768 | Availability Loan can not(reference room) | Due Date | Make a Reservation | Service |
Contents information
Book Introduction
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.Information Provided By: :
Author Introduction
World Health Organization(지은이)
<WHO 음용수 수질 가이드라인>