How to demonstrate foreign building compliance with drug good manufacturing practices.: H139-89/2018E-PDF
"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.
Permanent link to this Catalogue record:
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| Title | How to demonstrate foreign building compliance with drug good manufacturing practices. |
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| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Later edition | How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). [2025 edition] |
| Format | Digital text |
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| Description | 1 online resource (35 pages, 1 unnumbered page) : colour illustration |
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