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| 02140nam 2200409zi 4500 |
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001 | 9.882942 |
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003 | CaOODSP |
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005 | 20221107170430 |
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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 | |a9780660335445 |
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040 | |aCaOODSP|beng|erda|cCaOODSP |
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043 | |an-cn--- |
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086 | 1 |aH139-6/2021E-PDF |
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245 | 00|aCleaning validation guide. |
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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 (37 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 des procédés de nettoyage. |
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500 | |aIssued also in HTML format. |
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500 | |a"GUI-0028." |
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500 | |a"June 29, 2021." |
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504 | |aIncludes bibliographical references (pages 35-37). |
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520 | |a"This document is for anyone involved in pharmaceutical, biological and radiopharmaceutical fabrication and packaging activities for drugs sold in Canada, including: regulated industry; inspectors and evaluators. It provides guidance on cleaning validation. It will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations)"--page 6. |
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650 | 0|aDrug factories|xEquipment and supplies|xCleaning|vHandbooks, manuals, etc. |
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650 | 0|aBiotechnology industries|xEquipment and supplies|xCleaning|vHandbooks, manuals, etc. |
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650 | 0|aMedical instruments and apparatus|xSterilization|vHandbooks, manuals, etc. |
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655 | 7|aHandbooks and manuals|2lcgft |
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710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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775 | 08|tGuide sur la validation des procédés de nettoyage.|w(CaOODSP)9.882944 |
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856 | 40|qPDF|s959 KB|uhttps://publications.gc.ca/collections/collection_2021/sc-hc/H139-6-2021-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/cleaning-validation-guidelines-guide-0028/document.html |
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