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Found 10 records similar to Good Manufacturing Practices Guidance Document

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

The site licensing system requires that all manufacturers, packagers, labellers, and importers be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements.

Last Updated: Sep. 9, 2021
Date Published:
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHP, site licensing, natural health products site licensing, good manufacturing practice requirements
Federal

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

Last Updated: Jul. 7, 2021
Date Published: Aug. 28, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Good manufacturing practices, guide, drug products, GUI-0001, requirements for good manufacturing practices, Part C, Division 2 of the Regulations, industry, health care professionals
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

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

The NHP MAP outlines the process applied by NNHPD to manage Product Licence Applications (PLA) for Natural Health Products (NHPs) submitted in accordance with the Natural Health Products Regulations (NHPR). The policy also outlines the responsibilities and expectations of NHP applicants throughout the application process.

Last Updated: Sep. 9, 2021
Date Published: Mar. 13, 2020
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, management of applications policy, NHP MAP, Product Licence Applications, Natural Health Products Regulations, responsibilities of NHP applicants
Federal

This guidance provides information relating to the interpretation and enforcement of section 3 and Schedule A to the Food and Drugs Act (FDA), as well as sections A.01.067 and A.01.068 of the Food and Drug Regulations (FDR) and sections 103.2 and 103.3 of the Natural Health Products Regulations (NHPR) (which exempt natural health products (NHPs) and nonprescription drugs from the FDA's general prohibition on labelling and advertising of preventative claims for the diseases listed in Schedule A).

Last Updated: Sep. 9, 2021
Date Published: May 18, 2017
Organization: Health Canada
Formats: HTML
Keywords:  Natural health products, NHP, Food and Drugs Act, FDA, schedule A, section 3, Health Canada 2010, Food and Drug Regulations, FDR
Federal

The Natural Health Products Regulations (NHP Regulations) do not specify whether raw materials are or are not included in the definition of a natural health product (NHP). The NHP definition mentions neither raw material (e.g., ginger root that has just been harvested) nor finished product (e.g., encapsulated ginger that is packaged and labelled for the consumer). The NHP Raw Material Policy clarifies at which point a material becomes an NHP, and therefore when product and site licensing requirements are triggered.

Last Updated: Sep. 9, 2021
Date Published: Nov. 30, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural health product, NHP, raw material policy, NHP raw material policy, NHP Regulations, NHP definition, finished product
Federal

This policy outlines Health Canada's current approach with respect to compounding of NHPs. The NHP Compounding Policy distinguishes between the manufacturing of natural health products, an activity regulated by the Natural Health Products Regulations (NHP Regulations), and the compounding of natural health products, an activity unregulated by NHP Regulations.

Last Updated: Sep. 9, 2021
Date Published: Nov. 30, 2019
Organization: Health Canada
Formats: HTML
Keywords:  Natural health product, NHP, compounding policy, NHP compounding policy, manufacturing of natural health products, regulated by NHP Regulations, unregulated by NHP Regulations
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
Date modified: