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

Overview

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

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 products.

The interpretations in this document have been adopted from those published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) in Guide to Good Manufacturing Practice for Medicinal Products Annexes. 

Who this guide is for

This guide is for people who work with sterile drugs as:

• fabricators
• packagers
• labellers
• testers

In this guide

• About this document
  1. Purpose
  2. Scope
  3. Introduction
• Guidance
  4. Manufacture of sterile medicinal products
     • Sterile products
       • General
       • Clean room and clean air device classification
       • Clean room and clean air device monitoring
       • Isolator technology
       • Blow/fill/seal technology
       • Terminally sterilised products
       • Aseptic preparation
       • Personnel
       • Premises
       • Equipment
       • Sanitation
       • Processing
       • Sterilisation
       • Sterilisation by heat
       • Moist heat
       • Dry heat
       • Sterilisation by radiation
       • Sterilisation with ethylene oxide
       • Filtration of drugs which cannot be sterilised in their final container
       • Finishing of sterile products
       • Quality control
  5. GMP Annex 1 Revision 2008
     • Clean room / clean air device classification
     • Clean room / clean air device monitoring
     • Microbiological monitoring
     • Media simulations
     • Bioburden monitoring
     • Provisions for environmental conditions for the handling of aseptically filled vials after leaving the aseptic processing area up until final sealing
• Appendices
  • Appendix A - Glossary
    • Acronyms
    • Terms
  • Appendix B - References
  • Appendix C - Questions and answers

View complete guide

Download PDF (501 KB, 43 pages)

Details and history

• Published: February 28, 2018
• Implementation: October 1, 2018
• Consulted: January 18, 2017- April 18, 2017

For assistance

Contact us by email: GMP_questions_BPF@hc-sc.gc.ca

Service standards: We answer to mail within 10 business days. If we can't answer your question right away. We will send you an estimate date.