Summary of Annex 3B to the Good manufacturing practices guide – Positron-emitting radiopharmaceuticals

Overview

This document is for people who work with positron-emitting radiopharmaceuticals (PERs).

It is an annex to the latest version of the Good manufacturing practices guide for drug products (GUI-0001) and Good manufacturing practices for active pharmaceutical ingredients (API) (GUI-0104). It will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations).

Who this guide is for

This guide is for people who work with positron-emitting radiopharmaceuticals (PERs) as:

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

In this guide

Table of contents

• About this document
  • 1.  Purpose
  • 2.  Scope
  • 3.  Introduction
• Guidance
  • 4.  Modified interpretations
    • Premises
      • C.02.004
    • Equipment
      • C.02.005
    • Personnel
      • C.02.006
    • Sanitation
      • C.02.007 and C .02.008
    • Raw material testing
      • C.02.009 and C .02.010
    • Manufacturing control
      • C.02.011 and C .02.012
    • Quality control department
      • C.02.013 to C.02.015
    • Packaging material testing
      • C.02.016 and C.02.017
    • Finished product testing
      • C.02.018 and C.02.019
    • Records
      • C.02.020 to C.02.024.1
    • Samples
      • C.02.025 and C.02.026
    • Stability
      • C.02.027 and C.02.028
    • Sterile products
      • C.02.029
• Appendices
  • Appendix A − Glossary
    • Abbreviations and acronyms
    • Terms
  • Appendix B − References
    • Canada
    • Other jurisdictions

View complete guide
Download PDF (1.5 MB, 34 pages)

Details and history

Published: September 15, 2020

Implementation: March 15, 2021

Consulted: July 5, 2018 – October 5, 2018. 

For assistance

By email: hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca

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