00000cam 2200000zi 4500 9.949160 CaOODSP 20260114161431 m o d f cr mn||||||||| 250317e20250702onca ob f000 0 eng d 9780660764429 CaOODSP eng rda CaOODSP n-cn--- H139-89/2025E-PDF How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). [2025 edition]. Ottawa, ON : Health Canada = Santé Canada, July 2, 2025. ©2025 1 online resource (52 pages) : illustrations text txt rdacontent computer c rdamedia online resource cr rdacarrier Issued also in French under title: Comment démontrer la conformité des bâtiments étrangers avec les bonnes pratiques de fabrication des médicaments (GUI-0080). "Pub.: 240968"--Page [2]. Includes bibliographical references. "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. Pharmaceutical industry Government policy Canada. Pharmaceutical policy Canada. Canada. Health Canada, issuing body. Comment démontrer la conformité des bâtiments étrangers avec les bonnes pratiques de fabrication des médicaments (GUI-0080). (CaOODSP)9.949161 How to demonstrate foreign building compliance with drug good manufacturing practices. [2018 edition] (CaOODSP)9.954631 PDF 684 KB https://publications.gc.ca/collections/collection_2025/sc-hc/H139-89-2025-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.html 240968