Risk classification guide for drug good manufacturing practices observations (GUI-0023) - Summary

Overview

These guidelines establish the approach applied for both the attribution of risk ratings to observations noted during drug establishment inspections, and the overall rating attributed to the inspection. These guidelines help ensure the uniform application of risk ratings to observations, and informs industry of the situations Health Canada considers unacceptable which will lead to Non-Compliant ratings following an inspection.

Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada.

Health Canada inspects establishments to assess their compliance with the Food and Drugs Act and associated regulations. When we conduct an inspection, we will use this document as a guide in how we assign risk to the observations noted during the drug establishment inspection.

Who this guide is for

This guide is for people who work with drugs as:

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

In this guide

About this document

1. Purpose
2. Scope
3. Introduction

Guidance

• 4.1 Assigning risk to an observation
• 4.2 Assigning an inspection rating

Appendices

• Appendix A Sample observations
  • Premises (C.02.004)
  • Equipment (C.02.005)
  • Personnel (C.02.006)
  • Sanitation (C.02.007, C.02.008)
  • Raw material testing (C.02.009, C.02.010)
  • Manufacturing control (C.02.011, C.02.012)
  • Quality control department (C.02.013, C.02.014, C.02.015)
  • Packaging material testing (C.02.016, C.02.017)
  • Finished product testing (C.02.018, C.02.019)
  • Records (C.02.020, C.02.021, C.02.022, C.02.023, C.02.024, C.02.024.1)
  • Samples (C.02.025, C.02.026)
  • Stability (C.02.027, C.02.028)
  • Sterile products (C.02.029)
    
• Appendix B – Glossary
  • Acronyms
  • Terms
    
• Appendix C – References
  • Annex to GUI-0001 – Selected Category IV Monograph Drugs (GUI-0066)
  • GMP and EL Enforcement Directive (POL-0004)
  • Laws and regulations
  • GMP Guidelines (GUI-0001)
  • GMP Guidelines for APIs (GUI-0104)
  • GMP for Medical Gases (GUI-0031)