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

From: Health Canada

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

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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