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have a well-designed and correctly implemented pharmaceutical quality system (also known as a quality management system) that incorporates good manufacturing practices (GMP) and quality risk management.You will also need the help and commitment of your suppliers and personnel at all levels of your establishment. You are responsible for meeting the requirements outlined in the Regulations and clarified in this guidance. You must not place consumers at risk because of poor safety, quality, efficacy, or for not complying with regulations.

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Pharmaceutical quality system Guiding principlesĭo you hold an establishment licence, or run an operation governed by Part C, Division 2 of the Food and Drug Regulations? If you do, you must make sure that you comply with these requirements-and the marketing or clinical trial authorization-when you fabricate, package, label, import, distribute, test and wholesale drugs. *Where applicable, depending on the nature of the activities.Ībout quality management 4.Checklist – GMP regulations by activityĬhart 1.0: GMP regulations applicable to which licensable activities This edition reflects recent regulatory amendments, clarifies existing requirements, incorporates common questions from industry, and provides an updated list of annexes. This document also takes into account current mutual recognition agreements (MRA) between Health Canada and other international regulatory authorities, as well as agreements with other parties. other regulatory agencies in other countries.

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the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

the International Council on Harmonisation (ICH).

the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).

The guidance in this document has been written with a view to harmonize with GMP standards from: So use this guide to help you develop specific approaches that meet your unique needs. Because of this, they allow for flexibility in approach.

Guidance documents are administrative and do not have the force of law. Also, as new technologies emerge, different approaches may be called for. Other ways of complying with GMP regulations will be considered with proper scientific justification. 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.

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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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