<?xml version="1.0" encoding="UTF-8"?><marc:collection xmlns:marc="http://www.loc.gov/MARC21/slim">
  <marc:record>
    <marc:leader>00000nam  2200000zi 4500</marc:leader>
    <marc:controlfield tag="001">9.882946</marc:controlfield>
    <marc:controlfield tag="003">CaOODSP</marc:controlfield>
    <marc:controlfield tag="005">20221107170431</marc:controlfield>
    <marc:controlfield tag="006">m     o  d f      </marc:controlfield>
    <marc:controlfield tag="007">cr |||||||||||</marc:controlfield>
    <marc:controlfield tag="008">191216t20212021onc     ob   f00| 0 eng d</marc:controlfield>
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      <marc:subfield code="a">CaOODSP</marc:subfield>
      <marc:subfield code="b">eng</marc:subfield>
      <marc:subfield code="e">rda</marc:subfield>
      <marc:subfield code="c">CaOODSP</marc:subfield>
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      <marc:subfield code="a">n-cn---</marc:subfield>
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      <marc:subfield code="a">H139-7/2021E-PDF</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="245" ind1="0" ind2="0">
      <marc:subfield code="a">Guide to validation :          </marc:subfield>
      <marc:subfield code="b">drugs and supporting activities.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="1">
      <marc:subfield code="a">Ottawa : </marc:subfield>
      <marc:subfield code="b">Health Canada = Santé Canada, </marc:subfield>
      <marc:subfield code="c">2021.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="264" ind1=" " ind2="4">
      <marc:subfield code="c">©2021</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="300" ind1=" " ind2=" ">
      <marc:subfield code="a">1 online resource (41 pages)</marc:subfield>
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      <marc:subfield code="a">text</marc:subfield>
      <marc:subfield code="b">txt</marc:subfield>
      <marc:subfield code="2">rdacontent</marc:subfield>
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      <marc:subfield code="a">computer</marc:subfield>
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      <marc:subfield code="2">rdamedia</marc:subfield>
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      <marc:subfield code="a">online resource</marc:subfield>
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    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in French under title: Guide sur la validation : médicaments et activités de soutien.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">Issued also in HTML format.</marc:subfield>
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    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">"GUI-0029."</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="500" ind1=" " ind2=" ">
      <marc:subfield code="a">"June 29, 2021."</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="504" ind1=" " ind2=" ">
      <marc:subfield code="a">Includes bibliographical references (pages 38-41).</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="520" ind1=" " ind2=" ">
      <marc:subfield code="a">"This document is for anyone involved in the fabrication, packaging/labelling, testing, importation, distribution and wholesaling of drugs. It describes how to properly qualify and validate drug manufacturing processes, facilities, equipment, utilities and analytical methods. The application of this document will vary depending on the nature of your operations"--page 5.</marc:subfield>
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      <marc:subfield code="a">Drugs</marc:subfield>
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      <marc:subfield code="a">Drugs</marc:subfield>
      <marc:subfield code="x">Testing</marc:subfield>
      <marc:subfield code="x">Government policy</marc:subfield>
      <marc:subfield code="z">Canada.</marc:subfield>
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    <marc:datafield tag="710" ind1="1" ind2=" ">
      <marc:subfield code="a">Canada. </marc:subfield>
      <marc:subfield code="b">Health Canada, </marc:subfield>
      <marc:subfield code="e">issuing body.</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="775" ind1="0" ind2="8">
      <marc:subfield code="t">Guide sur la validation : </marc:subfield>
      <marc:subfield code="w">(CaOODSP)9.882949</marc:subfield>
    </marc:datafield>
    <marc:datafield tag="856" ind1="4" ind2="0">
      <marc:subfield code="q">PDF</marc:subfield>
      <marc:subfield code="s">1.27 MB</marc:subfield>
      <marc:subfield code="u">https://publications.gc.ca/collections/collection_2021/sc-hc/H139-7-2021-eng.pdf</marc:subfield>
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      <marc:subfield code="q">HTML</marc:subfield>
      <marc:subfield code="s">N/A</marc:subfield>
      <marc:subfield code="u">https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/validation-guidelines-pharmaceutical-dosage-forms-0029.html</marc:subfield>
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      <marc:subfield code="a">200033</marc:subfield>
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