| 000 | 00000nam u22002051a 4500 | |
| 001 | 000045802222 | |
| 005 | 20240816174309 | |
| 008 | 140617s2013 a i000 eng | |
| 020 | ▼a 9789241209861 | |
| 040 | ▼a 211009 ▼c 211009 ▼d 211009 | |
| 082 | 0 4 | ▼a 610.8 ▼2 22 |
| 090 | ▼a 610.8 ▼b t ▼c 986 | |
| 245 | 1 0 | ▼a WHO Expert Committee on Specifications for Pharmaceutical Preparations : ▼b Forty-eighth report / ▼c WHO Expert Committee on Specifications for Pharmaceutical Preparations. |
| 260 | ▼a Geneva : ▼b World Health Organization, ▼c 2013[2013]. | |
| 300 | ▼a 75 pages : ▼b ill ; ▼c 24 cm. | |
| 490 | 1 | ▼a WHO technical report series, ▼x 0512-3054 ; ▼v 986 |
| 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. |
소장정보
| No. | 소장처 | 청구기호 | 등록번호 | 도서상태 | 반납예정일 | 예약 | 서비스 |
|---|---|---|---|---|---|---|---|
| No. 1 | 소장처 학술정보관(CDL)/B1 국제기구자료실(UN)/UN-W | 청구기호 610.8 t 986 | 등록번호 181009634 | 도서상태 대출불가(자료실) | 반납예정일 | 예약 | 서비스 |
컨텐츠정보
책소개
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, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.
정보제공 :
저자소개
World Health Organization(지은이)
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