Explanatory notes for drug establishments on the preparation of a site master file (GUI-0005) - Summary


The aim of this document is to guide the preparation of the site master file.

These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Food and Drug Regulations.

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 (the Act) and associated regulations.

Important notice

This guide is based on the Pharmaceutical Inspection Cooperation Scheme (PIC/S) document Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) (PE 008-4). This guide reflects changes necessary to adapt the text to meet Canadian requirements.

Who this guide is for

Any person who conducts any of the licensable activities listed below with respect to a drug:

  • fabrication
  • packaging
  • labelling
  • testing

In this guide

  1. About this document
    1. Purpose
    2. Scope
    3. Introduction
  2. Content of site master file
    1. General information on the manufacturer
    2. Quality management system of the manufacturer
    3. Personnel
    4. Premises and equipment
    5. Documentation
    6. Production
    7. Quality control (QC)
    8. Distribution, complaints, product defects and recalls
    9. Self-inspections
  3. Appendices

View complete guide

Download PDF (1,125 KB, 14 pages)

Details and history

Published: July 17, 2020

Updated: July 17, 2020

For assistance

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