Annex 1 to the Good manufacturing practices guide - Manufacture of sterile drugs (GUI-0119) - Summary

Date implemented: The implementation period for most of the requirements outlined in this new guidance will end on April 1, 2024. For the requirements outlined in the lyophilization section, the implementation period will end on August 25, 2024.

Replaces: Annex 1 to the Good manufacturing practices guide: Manufacture of sterile drugs (GUI-0119), February 28, 2018

Disclaimer: This document does not constitute legislation. If there is any inconsistency or conflict between the legislation and this document, the legislation takes precedence. This is an administrative document intended to facilitate compliance by the regulated party with the legislation and the applicable administrative policies.

On this page

• Purpose
• Introduction

Purpose

This document provides guidance for fabricating and packaging/labelling sterile drugs.

It 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 sterile drugs. Refer to the glossary page for terms used in this guide.

The interpretations in this document have been adopted from those published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in the PIC/S GMP Guide Annexes.

The international norms referenced in this document (for example, International Organization for Standardization (ISO) standards) were applicable at the time it was drafted. Relevant updates of these norms will be reflected in a future version of this document.

These guidelines apply to these types of sterile drugs:

• biological
• veterinary
• pharmaceutical
• radiopharmaceutical

The scope of this document does not include establishment licensing.

To comply with GMP requirements in order to get an establishment licence, consult:

• Guidance on drug establishment licences (GUI-0002)

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

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

Introduction

These guidelines interpret the requirements for manufacturing sterile drugs in Part C, Division 2, section C.02.029 of the Food and Drug Regulations (regulations).

Health Canada is an active participating member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). In 2018, we adopted the PIC/S guidance Annex 1, Manufacture of sterile medicinal products, which describes how to manufacture sterile drugs in compliance with C.02.029 of the regulations. This 2018 adoption enabled transition to the 2023 version of the guidance.

Health Canada prepared this guidance in cooperation with the European Medicines Agency (EMA), World Health Organization (WHO) and PIC/S in order to align with global standards, all while assuring the highest quality document possible. The document is subject to parallel adoption by the European Commission, WHO and PIC/S.

Guidance documents like this one help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff so that the regulations 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. Our inspectors will use this document as a guide to assess your compliance with GMP requirements for sterile drugs.

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 called for.

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 to meet your unique needs.