Guidance Document Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines - Veterinary Drugs (GUI-0012)

Date issued: March 25, 2024

Date implemented: March 25, 2024

Replaces: Annex 4 to the Good Manufacturing Practices Guidelines - Veterinary drugs (May 13, 2011)

On this page

• Purpose
• Scope
• Introduction

Purpose

This document is for people who work with veterinary drugs as:

• fabricators
• packagers
• labellers
• testers
• distributors
• importers

This guide is an annex to the Good manufacturing practices guide for drug products (GUI-0001). You must read the 2 documents together to understand all relevant guidelines. These guides will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (FDR), which is about good manufacturing practices (GMP).

For an explanation of the terms used in this guide, refer to Definitions.

Scope

This annex applies to the manufacture of veterinary drugs that are subject to Part C Division 2 of the FDR.

It does not apply to:

• veterinary biologics
  • regulated under the Health of Animals Act and the Health of Animals Regulations
• dilute drug premixes and medicated feeds
• veterinary health products
• premixes containing only vitamin and mineral ingredients
  • regulated by the Feeds Act and are not considered drugs

The scope of this document does not include:

• establishment licensing
• active pharmaceutical ingredients

To understand how to comply with GMP requirements to get an establishment licence, consult the:

• Guidance on drug establishment licences (GUI-0002)

For information on the guidelines for active pharmaceutical ingredients (APIs), consult the:

• Good manufacturing practices for active pharmaceutical ingredients (GUI-0104)

Introduction

The regulations and the rationales outlined in the Good manufacturing practices guide for drug products (GUI-0001) apply to all veterinary drugs. However, in some situations, certain guidelines are not applicable or appropriate. This document aims to clarify those exceptions.

The guidance in this annex has been separated into 3 tabbed pages to reflect the different production methods and handling techniques for veterinary drugs:

• all veterinary drugs except those covered in the tabbed pages for non-sterile, non-prescription veterinary drugs and for veterinary drug premixes
• non-sterile, non-prescription veterinary drugs with no withdrawal period for all approved species and veterinary drugs that are subject to a published veterinary monograph
• veterinary drug premixes

For non-segregated facilities that manufacture more than 1 class of drugs covered by this annex, the most stringent interpretation would apply.

Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced fairly, consistently and effectively across Canada.

Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (act) and associated regulations. When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements.

These guidelines are not the only way GMP regulations can be interpreted, and are not intended to cover every possible case. Other ways of complying with GMP regulations will be considered with proper scientific justification. Also, as new technologies emerge, different approaches may be called for.

Guidance documents are administrative and do not have the force of law. Because of this, they allow for flexible approaches. Use this guide to help you develop specific approaches that meet your unique needs.