000
| 01925cam 2200385zi 4500 |
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001 | 9.882946 |
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003 | CaOODSP |
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005 | 20221107170431 |
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006 | m o d f |
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007 | cr ||||||||||| |
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008 | 191216t20212021onc ob f00| 0 eng d |
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020 | |a9780660335469 |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH139-7/2021E-PDF |
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245 | 00|aGuide to validation : |bdrugs and supporting activities. |
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264 | 1|aOttawa : |bHealth Canada = Santé Canada, |c2021. |
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264 | 4|c©2021 |
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300 | |a1 online resource (41 pages) |
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336 | |atext|btxt|2rdacontent |
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337 | |acomputer|bc|2rdamedia |
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338 | |aonline resource|bcr|2rdacarrier |
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500 | |aIssued also in French under title: Guide sur la validation : médicaments et activités de soutien. |
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500 | |aIssued also in HTML format. |
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500 | |a"GUI-0029." |
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500 | |a"June 29, 2021." |
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504 | |aIncludes bibliographical references (pages 38-41). |
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520 | |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. |
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650 | 0|aDrugs|xTesting|xStandards. |
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650 | 0|aDrugs|xTesting|xGovernment policy|zCanada. |
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710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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775 | 08|tGuide sur la validation : |w(CaOODSP)9.882949 |
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856 | 40|qPDF|s1.27 MB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H139-7-2021-eng.pdf |
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856 | 4 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/validation/validation-guidelines-pharmaceutical-dosage-forms-0029.html |
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