![]() ![]() These guidelines are not the only way GMP regulations can be interpreted, and are not intended to cover every possible case. To better understand how risk ratings are assigned during inspections, see Risk classification guide for drug good manufacturing practices observations (GUI-0023). ![]() When we conduct an inspection, we will use this document as a guide in assessing your compliance with GMP requirements. Health Canada inspects establishments to assess their compliance with the Food and Drugs Act (the Act) and associated regulations. They also provide guidance to Health Canada staff, so that the rules are enforced in a fair, consistent and effective way across Canada. Guidance documents like this one are meant to help industry and health care professionals understand how to comply with regulations. They were developed by Health Canada in consultation with stakeholders. These guidelines interpret the requirements for good manufacturing practices (GMP) in Part C, Division 2 of the Regulations. The scope of this document does not include:Įstablishment licensing - To understand how to comply with GMP requirements to get an establishment licence, see Guidance on Drug Establishment Licences (GUI-0002).Īctive pharmaceutical ingredients - Guidelines for active pharmaceutical ingredients (APIs) are described in Health Canada's Good manufacturing practices for active pharmaceutical ingredients (GUI-0104). The following table shows the three types of icons used in this document, and the way they are intended to be used. Developing a pharmaceutical quality system. ![]() Checklist – GMP regulations by activity.This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the regulations and the applicable administrative policies. This document does not constitute part of the Food and Drugs Act (the Act) or its regulations and in the event of any inconsistency or conflict between the Act or regulations and this document, the Act or the regulations take precedence. ![]()
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