Annex 2 to the Good manufacturing practices guide - Manufacture of biologics (GUI-0027): Overview

Date issued: 04-07-2024

Date implemented: 04-07-2024

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

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Purpose

This guide is for people who work with drugs listed in Schedule D to the Food and Drugs Act (act) and regulated under the Food and Drug Regulations (FDR) ("biologics"), such as:

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

This guide is an annex to the current edition of the Good manufacturing practices guide for drug products (GUI-0001). It will help you understand and comply with good manufacturing practices (GMP) for biologics.

To avoid repetition, only interpretations that are in addition to those included in GUI-0001 are contained in this annex. Unless otherwise stated in this annex, all interpretations included in GUI-0001 apply to biologics and their bulk process intermediates.

The interpretations in this document have been adapted from those published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in Annex 2B and Annex 14. Refer to:

For terms used in this guide, refer to Definitions.

Scope

This guide focuses on the licensable activities under the FDR of:

  • biologics for human use
  • bulk process intermediates
  • bulk process intermediate drugs in dosage form, with the exception of gene, cell and tissue therapies and
  • the processing of apheresis plasma for manufacturing under the Blood Regulations

Gene, cell and tissue therapies will be covered in a separate guide, GUI-0154. Manufacturers of gene, cell and tissue therapy products may consult PIC/S Annex 2A - Manufacture of advanced therapy medicinal products for human use.

This guide applies to biologics used in clinical trials as per Division 5 of the FDR.

This guidance has been adapted from:

  • Annex 2B: Manufacture of biological medicinal substances and products for human use
  • Annex 14: Manufacture of products derived from human blood or plasma

Both annexes are in the following Pharmaceutical Inspection Cooperation Scheme (PIC/S) document:

For more information on the GMP requirements for drugs used in clinical trials as set out in Division 5 of the FDR, consult:

The scope of this document does not include:

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

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

The processing of whole blood and its components for transfusion under the Blood Regulations, consult:

Cells, tissues and organs regulated under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations, consult:

Introduction

The regulations that pertain to biologics are mainly found in Part C, Divisions 1A, 2, 4, 5 and 8 of the FDR.

This guide interprets the requirements for biologics manufacturing in Part C, Division 2 of the FDR. The requirements of Division 2 apply to biologics, both as bulk process intermediates and in dosage form.

As described in GUI-0002 (Guidance on Drug Establishment Licences), Bulk Product Intermediates include active ingredients of biological origin used in the manufacture of finished dosage form drugs that are listed on Schedule C (radiopharmaceutical drugs) or Schedule D (biologic drugs) of the FDA.

Guidance documents like this one, which is adapted from PIC/S Annexes 2B and 14, are meant to help industry and health care professionals understand how to comply with the relevant Canadian legislation. They also provide guidance to Health Canada staff so that the regulations are enforced fairly, consistently and effectively.

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 to assess your compliance with the relevant GMP requirements for biologics.

As part of the premarketing evaluation process and following authorization, biologics may also be subject to an on-site evaluation (OSE) of manufacturing sites and the testing of consistency lots,. These measures add to Health Canada's risk-based oversight under the Lot Release Program.

These guidelines are not the only way to interpret GMP regulations and do not 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 used.

For a full list of Canadian and international references, refer to References.

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

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