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Found 10 records similar to Good manufacturing practices guide for drug products (GUI-0001) - Summary

Federal

Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food and Drug Regulations. Section C.05.010(j) requires the sponsor to ensure that drugs for use in clinical trials are manufactured, handled and stored in accordance with the applicable Good Manufacturing Practices requirements referred to in Divisions 2 to 4, except for Sections C.02.019, C.02.025 and C.02.026. Sponsors of clinical trials shall ensure that imported drugs are fabricated and packaged/labelled in accordance with these requirements.

Last Updated: Jun. 7, 2022
Date Published: Nov. 16, 2020
Organization: Health Canada
Formats: HTML
Keywords:  good manufacturing practices, guidance document, drugs-used in clinical-trials, GUI-0036
Federal

This document will provide guidance to federally regulated holders of a licence under the Cannabis Act on how to meet the requirements of Part 5: Good Production Practices (GPP) of the Cannabis Regulations.

Last Updated: Jun. 27, 2022
Date Published: Dec. 4, 2019
Organization: Health Canada
Formats: HTML
Keywords:  cannabis, good-production-practices guide, production-guide for cannabis, federally regulated licence-holders, licence under the-Cannabis-Act
Federal

This guidance document pertains to Part 3 of the Natural Health Product Regulations (the Regulations) and is intended for manufacturers, packagers, labellers, importers, and distributors of natural health products (NHPs) for sale in Canada.

Last Updated: Sep. 9, 2021
Date Published: Jul. 22, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, good manufacturing practices, Natural Health Product Regulations, Part 3 of the Regulations, manufacturers, packagers, labellers, importers
Federal

This document clarifies the requirements to be met for the issuance of a Certificate of a Pharmaceutical Product (CPP) or a certificate of Good Manufacturing Practices (GMP) and describes the procedure for their request.

Last Updated: Dec. 29, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  pharmaceutical product, Certificate of Pharmaceutical-Product, CPP, good-manufacturing-practice, certificate of Good-Manufacturing-Practices, GMP, GUI-0024
Federal

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

Last Updated: Jul. 8, 2021
Date Published: Feb. 16, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Notice, submission filing recommendations, veterinary drugs, good manufacturing practices, drug establishment licences
Federal

Evidence of Good Manufacturing Practices (GMP) for drug submissions. The goal of this revision is to better align the drug submission screening and review process with the Drug Establishment Licence (DEL) process. This should allow sponsors to make timely drug submissions while still providing adequate assurance of an establishment’s commitment to quality.

Last Updated: Jul. 8, 2021
Date Published: Feb. 10, 2017
Organization: Health Canada
Formats: HTML
Keywords:  drug submission, submission filing requirements, good manufacturing practices, GMP, drug establishment licences
Federal

Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. When doing these activities, companies must follow good manufacturing practices requirements (NHP GMPs) in the Natural Health Product Regulations (NHPR). It is a company’s responsibility to comply with the applicable regulatory requirements. When we identify an issue, we take compliance and enforcement actions based on several factors such as the risk to your health.

Last Updated: Sep. 9, 2021
Date Published: Feb. 4, 2021
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHPs, good manufacturing practices requirements, NHP GMPs, site licence, manufacture, package, label, import natural health products
Federal

This guidance document will help anyone who is involved in the conduct of clinical trials of drugs in humans to understand and comply with Part C, Division 5 of the Food and Drug Regulations (the Regulations).

Last Updated: May 4, 2021
Date Published: Aug. 21, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Guidance, Part C, Division 5, Food and Drug Regulations, Drugs for Clinical Trials, Clinical Trials Involving Human Subjects, GUI-0101
Federal

Division 1A of Part C of the Regulations applies to COVID-19 drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.

Last Updated: Jul. 29, 2021
Date Published: Jun. 23, 2021
Organization: Health Canada
Formats: HTML
Keywords:  COVID-19, pandemic, COVID-19 drug, amendement, Food and Drug Regulations, drugs, manufacturers, submission, notice of compliance
Federal

Links to Health Canada guidance documents related to Good Clinical Practices

Last Updated: Jun. 7, 2022
Date Published: Dec. 6, 2021
Organization: Health Canada
Formats: HTML
Keywords:  clinical trials, good clinical practices, guidance documents, guidance documents on good-clinical-practices
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