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<title>WHO Expert Committee On Specifications For Pharmaceutical Preparations</title>
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<name type="Personal Name" authority="">
<namePart>World Health Organization</namePart>
<role><roleTerm type="text">Primary Author</roleTerm></role>
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<place><placeTerm type="text">Geneva  Switzerland</placeTerm></place>
<publisher>WHO</publisher>
<dateIssued>2010</dateIssued>
<issuance>continuing</issuance>
<frequency>Weekly</frequency>
<edition>Forty-Fourth report</edition>
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<languageTerm type="code">en</languageTerm>
<languageTerm type="text">English</languageTerm>
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<form authority="gmd">Buku Teks</form>
<extent>xi, 276 hlm.; 24 cm.</extent>
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<titleInfo>
<title>Technology,Pharmaceuticals Standards</title>
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<note>The expert Committee on Specificatios for Pharmaceutical Preparations Works Towards clear,independent and practical standards and guielines for the quality assurance of medicines. Standar are develoved by the Committee through worldwide consultation and an international conesensus-building process. The Following new guidelines were adopted and recommended for use: good practices for pharmaceutical quality controllaboratories; supplementary guidelines for active pharmaceutical ingridients; good manufacturing practices for pharmaceutical products containing hazardous substances; good manufacturing practices for sterile pharmaceutical products;guidelines on the requalification of prequalified dossiers; and quidelines for the preparation of a contract resarch organization master file.</note>
<subject authority=""><topic>Pharmaceutical Preparations</topic></subject>
<classification>615</classification><identifier type="isbn">9789241209571</identifier><recordInfo>
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