MARC details
| 000 -LEADER |
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| fixed length control field |
04613cam a22005777a 4500 |
| 001 - CONTROL NUMBER |
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| control field |
17071169 |
| 003 - CONTROL NUMBER IDENTIFIER |
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| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
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| control field |
20180724122404.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
111205s2010 sz a b 000 0 eng d |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
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| LC control number |
2011293946 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9789241209618 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
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| International Standard Book Number |
9241209615 |
| 035 ## - SYSTEM CONTROL NUMBER |
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| System control number |
(OCoLC)ocn731183154 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
HNC |
| Transcribing agency |
HNC |
| Modifying agency |
TPH |
| -- |
GZQ |
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AGL |
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BTCTA |
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NZWMM |
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YDXCP |
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HPH |
| -- |
DLC |
| 042 ## - AUTHENTICATION CODE |
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| Authentication code |
lccopycat |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
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| Classification number |
RS189 |
| Item number |
.W4753 2011 |
| 060 14 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER |
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| Classification number |
WA16 |
| Item number |
W676t no.961 2011 |
| 070 0# - NATIONAL AGRICULTURAL LIBRARY CALL NUMBER |
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| Classification number |
RA189 |
| Item number |
.W55 2011 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
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| Classification number |
615.1 |
| Edition number |
22 |
| 245 00 - TITLE STATEMENT |
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| Title |
WHO Expert Committee on Specifications for Pharmaceutical Preparations : |
| Remainder of title |
forty-fifth report. |
| 246 3# - VARYING FORM OF TITLE |
|---|
| Title proper/short title |
World Health Organization Expert Committee on Specifications for Pharmaceutical Preparations |
| 246 18 - VARYING FORM OF TITLE |
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| Title proper/short title |
Specifications for Pharmaceutical Preparations |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
Geneva, Switzerland : |
| Name of publisher, distributor, etc |
World Health Organization, |
| Date of publication, distribution, etc |
c2011. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xii, 428 p. : |
| Other physical details |
ill. ; |
| Dimensions |
24 cm. |
| 336 ## - CONTENT TYPE |
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| Source |
rdacontent |
| Content type term |
text |
| 337 ## - MEDIA TYPE |
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| Source |
rdamedia |
| Media type term |
unmediated |
| 338 ## - CARRIER TYPE |
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| Source |
rdacarrier |
| Carrier type term |
volume |
| 490 1# - SERIES STATEMENT |
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| Series statement |
WHO Technical report series, |
| International Standard Serial Number |
0512-3054 ; |
| Volume number/sequential designation |
961 |
| 500 ## - GENERAL NOTE |
|---|
| General note |
The WHO Expert Committee met in Geneva from October 18-22, 2010. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references. |
| 505 0# - FORMATTED CONTENTS NOTE |
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| Formatted contents note |
Introduction -- General policy -- Joint session with the Expert Committee on Biological Standardization -- Quality control: specifications and tests -- Quality control: international reference materials (International Chemical Reference Substances and International Infrared Reference Spectra) -- Quality control: national laboratories -- Quality assurance: good manufacturing practices -- Quality assurance: new approaches -- Quality assurance: distribution and trade of pharmaceuticals -- Prequalification of priority essential medicines -- Prequalification of quality control laboratories -- Prequalification of active pharmaceutical ingredients -- Regulatory guidance -- Nomenclature, terminology and databases -- Summary and recommendations -- Annexes. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
This report gives recommendations and provides independent international standards and guidelines in the area of quality assurance for implementation by WHO Member States, international organizations, United Nations agencies, regional and interregional harmonization efforts, as well as WHO's medicines' related programs and initiatives.<br/><br/>During the 45th meeting the following new and revised guidelines were adopted and are thus annexed to the report: Procedure for adoption of ICRS (revised), Good Pharmacy Practice (joint FIP/WHO, revised), Guidance for Pharmaceutical Microbiology laboratories (new), Procedure for prequalification of laboratories (revised), WHO guidelines for preparing a laboratory information file, GMP: main principles (revised), GMP for blood establishments (jointly with ECBS), GMP for HVAC (revised), GMP for sterile pharmaceutical products (revised), Guidelines for the preparing a Site Master File (new), Guiding principles on transfer of technology (new), Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products (new, jointly with ECBS), Guidance on submission of documentation for prequalification of innovator FPPS approved by stringent regulatory authorities (new), Procedure for prequalification of medicines (revised), Guideline for the submission of documentation for a multisource (generic) finished product (new) and Special guidance for artemisinin as a starting material for production of antimalarials (subject to confirmation of impurity profile, new). |
| 530 ## - ADDITIONAL PHYSICAL FORM AVAILABLE NOTE |
|---|
| Additional physical form available note |
Also available via World Wide Web. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Standards |
| Form subdivision |
Congresses. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Specifications |
| Form subdivision |
Congresses. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Quality control |
| Form subdivision |
Congresses. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmacopoeias |
| Form subdivision |
Congresses. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Industry |
| General subdivision |
standards |
| Form subdivision |
Congresses. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Preparations |
| General subdivision |
standards |
| Form subdivision |
Congresses. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmacopoeias as Topic |
| Form subdivision |
Congresses. |
| 650 12 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Reference Standards |
| Form subdivision |
Congresses. |
| 650 22 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Quality Control |
| Form subdivision |
Congresses. |
| 655 #2 - INDEX TERM--GENRE/FORM |
|---|
| Genre/form data or focus term |
Congresses. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
World Health Organization. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
WHO Expert Committee on Specifications for Pharmaceutical Preparations |
| Number of part/section/meeting |
(45th : |
| Date of meeting or treaty signing |
2010 : |
| Location of meeting |
Geneva, Switzerland) |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Technical report series (World Health Organization) ; |
| Volume number/sequential designation |
961. |
| 856 41 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
<a href="http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf">http://whqlibdoc.who.int/trs/WHO_TRS_961_eng.pdf</a> |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
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| a |
7 |
| b |
cbc |
| c |
copycat |
| d |
2 |
| e |
ncip |
| f |
20 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Books |