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
- 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
- Appendix C – References
Related guides and help
- Good Manufacturing Practices (GMP) guidelines (GUI-0001)
- Guidance on Drug Establishment Licences (GUI-0002)
- Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
- Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients (API) - (GUI-0104)
- Annex 1 to the Good manufacturing practices guide – Manufacture of sterile drugs (GUI-0119)
- Annex 1 to the Current Edition of the Good Manufacturing Practices Guidelines – Selected Category IV Monograph Drugs (GUI-0066)
- Annex 2 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule D Drugs, Biological Drugs (GUI-0027)
- Annex 3 to the Current Edition of the Good Manufacturing Practices Guidelines – Schedule C Drugs (GUI-0026)
- Annex 4 to the Current Edition of the Good Manufacturing Practices Guidelines – Veterinary Drugs (GUI-0012)
- Annex 5 to the Current Edition of the Good Manufacturing Practices Guidelines – Positron Emitting Radiopharmaceuticals (PER's) (GUI-0071)
- Annex 11 – PIC/S Annex 11: Computerised Systems
- Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines – Drugs Used in Clinical Trials (GUI-0036)
- Annex 17 – PIC/S Annex 17: Guidance on Parametric Release
- Good manufacturing practices for medical gases (GUI-0031)
Related acts and regulations
Related program
Download PDF (401 KB, 30 pages)
Details and history
Published: August 31, 2020
Implementation: August 31, 2020
Consulted: January 18, 2017 – April 18, 2017
For assistance
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.
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