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008250829e20180118onca    ob   f000 0 eng d
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH139-89/2018E-PDF
24500|aHow to demonstrate foreign building compliance with drug good manufacturing practices.
24617|aHow to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
250 |a[2018 edition].
264 1|a[Ottawa] : |bHealth Canada = Santé Canada, |cJanuary 18, 2018.
300 |a1 online resource (35 pages, 1 unnumbered page) : |bcolour illustration
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Comment démontrer la conformité des établissements étrangers avec les bonnes pratiques de fabrication des médicaments.
500 |aTitle from cover.
500 |a"GUI-0080."
504 |aIncludes bibliographical references.
520 |a"This guide is for Canadian importers who want to list a foreign building on their drug establishment licence (DEL). It provides guidance on the type of information you should submit to support your DEL amendment 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 (finished dosage forms (FDF) or active pharmaceutical ingredients (API), including any FDF and API intermediates) for import into Canada or import into Canada for future export"--Purpose, page 4.
650 0|aPharmaceutical industry|xGovernment policy|zCanada.
650 0|aPharmaceutical policy|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tComment démontrer la conformité des établissements étrangers avec les bonnes pratiques de fabrication des médicaments.|w(CaOODSP)9.954632
794 |tHow to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).|b[2025 edition]|w(CaOODSP)9.949160
85640|qPDF|s568 KB|uhttps://publications.gc.ca/collections/collection_2025/sc-hc/H139-89-2018-eng.pdf
8564 |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/document.html