| 000 | 00000cam u2200205 a 4500 | |
| 001 | 000046076087 | |
| 005 | 20240816175428 | |
| 008 | 210402s2015 sz a b i000 0 eng d | |
| 020 | ▼a 9789241209922 | |
| 035 | ▼a (KERIS)BIB000014122243 | |
| 040 | ▼a 224010 ▼c 224010 ▼d 211009 | |
| 082 | 0 4 | ▼a 610.8 ▼a 615.1 ▼2 23 |
| 084 | ▼a 610.8 ▼2 DDCK | |
| 090 | ▼a 610.8 ▼b t ▼c 992 | |
| 245 | 0 0 | ▼a WHO Expert Committee on Specifications for Pharmaceutical Preparations : ▼b forty-ninth report / ▼c WHO Expert Committee on Specifications for Pharmaceutical Preparations. |
| 246 | 1 | ▼a Forty-ninth report of the WHO Expert Committee on specifications for pharmaceutical preparations |
| 246 | 3 0 | ▼a Specifications for Pharmaceutical Preparations |
| 260 | ▼a Geneva, Switzerland : ▼b World Health Organization, ▼c c2015. | |
| 300 | ▼a xi, 210 p. : ▼b ill. ; ▼c 24 cm. | |
| 490 | 1 | ▼a WHO technical report series, ▼x 0512-3054 ; ▼v 992 |
| 504 | ▼a Includes bibliographical references. | |
| 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 Expert Committee on Specifications for Pharmaceutical Preparations. |
| 710 | 2 | ▼a WHO ▼0 AUTH(211009)64026. |
| 710 | 2 | ▼a World Health Organization. |
| 830 | 0 | ▼a Technical report series (World Health Organization) ; ▼v 992. |
| 945 | ▼a KLPA |
소장정보
| No. | 소장처 | 청구기호 | 등록번호 | 도서상태 | 반납예정일 | 예약 | 서비스 |
|---|---|---|---|---|---|---|---|
| No. 1 | 소장처 학술정보관(CDL)/B1 국제기구자료실(UN)/UN-W | 청구기호 610.8 t 992 | 등록번호 181009928 | 도서상태 대출불가(자료실) | 반납예정일 | 예약 | 서비스 |
컨텐츠정보
책소개
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 and HealthCare, the custodian center 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 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. It adopted eight guidelines and 16 technical supplements, 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.
정보제공 :
