How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080).: H139-89/2025E-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.949160&sl=0
| Department/Agency |
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|---|---|
| Title | How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080). |
| Publication type | Monograph |
| Language | [English] |
| Other language editions | [French] |
| Earlier edition | How to demonstrate foreign building compliance with drug good manufacturing practices. [2018 edition] |
| Format | Digital text |
| Electronic document | |
| Note(s) |
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| Publishing information |
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| Description | 1 online resource (52 pages) : illustrations |
| ISBN | 9780660764429 |
| Catalogue number |
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| Departmental catalogue number | 240968 |
| Edition |
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| Subject terms |
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