How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080): Overview

Disclaimer: This document does not constitute part of the Food and Drugs Act (FDA) or its regulations. In the event of any inconsistency or conflict between the FDA or regulations and this document, the act or regulations takes precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the FDA, the regulations and the applicable administrative policies.

On this page

• Purpose
• Scope
• Introduction

Purpose

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.

Scope

These guidelines apply to importers of drugs for human and veterinary use from foreign buildings.

There may also be scenarios where a DEL holder must list a foreign building on their DEL for licensable activities not related to import. For example, DEL holders that use a foreign building solely as a third-party testing site must also follow the guidance in this document.

Foreign building licensable activities within scope:

• fabrication
• packaging/labelling
• testing

Drug categories within scope:

• pharmaceutical drugs
  • includes medical gases
• active ingredients
• vaccines
  • Schedule D to the FDA
• biological drugs
• Schedule D to the FDA
• radiopharmaceutical drugs
  • Schedule C to the FDA
• prescription drugs
  • set out in the Prescription Drug List
• controlled drugs
  • defined in section01.001 of the FDR
• narcotics
  • defined in the Narcotic Control Regulations
• drugs containing cannabis
  • defined in subsection 2(1) of the Cannabis Act
• APIs set out in List A that are for veterinary use

For more information on drug categories, consult:

• Guidance on drug establishment licences (GUI-0002)

These guidelines also apply to foreign buildings that retain samples of a drug in dosage form on behalf of a Canadian importer or distributor. This is outlined in section C.02.025(1) of the FDR.

This document does not cover foreign buildings that perform activities with products that do not fall under Part C, Division 1A of the FDR. As well, it does not include foreign buildings that perform activities with:

• cannabis for medical and non-medical purposes
• cells, tissues and organs for transplantations
• excipients
  • non-medicinal components of a drug product
• drugs used in clinical trials
• drugs used for research and development
• medical devices
• natural health products as defined in the Natural Health Products Regulations
• veterinary vaccines and select veterinary immunomodulators that fall within the scope of the Canadian Food Inspection Agency (that is, veterinary products without a drug identification number (DIN))
• whole blood for transfusion

Introduction

When a drug is fabricated, packaged/labelled or tested outside of Canada, the foreign building where those activities occur must be listed on the Canadian importer’s DEL. To be listed on the DEL, the foreign building must be compliant with good manufacturing practices (GMP) requirements. These requirements are described in Part C, Divisions 2 to 4 of the FDR.

It’s your responsibility as a Canadian importer to ensure that drugs fabricated, packaged/labelled or tested outside of Canada and imported for sale in Canada comply with GMP requirements.

This guidance document outlines:

• when and how to submit GMP evidence to support the compliance of a foreign building
• what GMP evidence must be submitted

Health Canada will assess the GMP evidence against the FDA and its associated regulations.