| 000 | 00000cam 2200000zi 4500 |
| 001 | 9.949160 |
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| 003 | CaOODSP |
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| 005 | 20260114161431 |
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| 006 | m o d f |
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| 007 | cr mn||||||||| |
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| 008 | 250317e20250702onca ob f000 0 eng d |
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| 020 | |a9780660764429 |
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| 040 | |aCaOODSP|beng|erda|cCaOODSP |
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| 043 | |an-cn--- |
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| 086 | 1 |aH139-89/2025E-PDF |
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| 245 | 00|aHow to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). |
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| 250 | |a[2025 edition]. |
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| 264 | 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cJuly 2, 2025. |
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| 264 | 4|c©2025 |
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| 300 | |a1 online resource (52 pages) : |billustrations |
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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: Comment démontrer la conformité des bâtiments étrangers avec les bonnes pratiques de fabrication des médicaments (GUI-0080). |
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| 500 | |a"Pub.: 240968"--Page [2]. |
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| 504 | |aIncludes bibliographical references. |
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| 520 | |a"This guide is for Canadian importers who want to list and maintain a foreign building on their drug establishment licence (DEL). It provides guidance on the type of information you should submit to support your DEL application. It will also help you understand how Part C, Division 2, Good Manufacturing Practices of the Food and Drug Regulations (FDR) applies to foreign buildings that supply Canadian importers with drugs for import into Canada or import into Canada for future export. This includes finished dosage forms (FDF), active pharmaceutical ingredients (API), and FDF and API intermediates"--Purpose, page 5. |
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| 650 | 0|aPharmaceutical industry|xGovernment policy|zCanada. |
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| 650 | 0|aPharmaceutical policy|zCanada. |
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| 710 | 1 |aCanada. |bHealth Canada, |eissuing body. |
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| 775 | 08|tComment démontrer la conformité des bâtiments étrangers avec les bonnes pratiques de fabrication des médicaments (GUI-0080).|w(CaOODSP)9.949161 |
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| 795 | |tHow to demonstrate foreign building compliance with drug good manufacturing practices.|b[2018 edition]|w(CaOODSP)9.954631 |
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| 856 | 40|qPDF|s684 KB|uhttps://publications.gc.ca/collections/collection_2025/sc-hc/H139-89-2025-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/guidance-documents/guidance-evidence-demonstrate-drug-compliance-foreign-sites-0080.html |
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| 986 | |a240968 |
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