Good manufacturing practices guide for drug products (GUI-0001) - Summary
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Related acts and regulations
Related program
Overview
These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. They were developed by Health Canada in consultation with stakeholders.
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 assessing your compliance with GMP requirements.
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
- About quality management
- Guidance
- Appendices
- Appendix A – Glossary
- Appendix B – Questions and answers
- 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.02015
- 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 C – References
Download PDF (2.4 MB, 159 pages)
Details and history
- Published: July 1, 2020
- Implementation: July 1, 2020
- Consulted: January 18, 2017 – April 18, 2017
For assistance
By email hc.drug.gmp.questions-bpf.medicaments.sc@canada.ca
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