00000nam 2200000zi 4500 9.954631 CaOODSP 20250829124648 m o d f cr mn||||||||| 250829e20180118onca ob f000 0 eng d CaOODSP eng rda CaOODSP n-cn--- H139-89/2018E-PDF How to demonstrate foreign building compliance with drug good manufacturing practices. How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080) [2018 edition]. [Ottawa] : Health Canada = Santé Canada, January 18, 2018. 1 online resource (35 pages, 1 unnumbered page) : colour illustration text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Comment démontrer la conformité des établissements étrangers avec les bonnes pratiques de fabrication des médicaments. Title from cover. "GUI-0080." Includes bibliographical references. "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. Pharmaceutical industry Government policy Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Comment démontrer la conformité des établissements étrangers avec les bonnes pratiques de fabrication des médicaments. (CaOODSP)9.954632 How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). [2025 edition] (CaOODSP)9.949160 PDF 568 KB https://publications.gc.ca/collections/collection_2025/sc-hc/H139-89-2018-eng.pdf HTML N/A https://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