Explanatory notes for drug establishments on the preparation of a site master file (GUI-0005) - Summary
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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.
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:
In this guide
- About this document
- Content of site master file
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Details and history
Published: July 17, 2020
Updated: July 17, 2020
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