Foreign Site Reference Number

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

23

Sep

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NHPsBatch Records, canadian regulations, CAPA, consulting experts, Data Integrity, Foreign Site Reference Number, FSRN, GMP, GUI-0158, health canada, Health Canada inspections, master production documents, natural health products, NHP, NHP importing, NHP manufacturing, QAP responsibilities, QMS, quality management system, quality risk management, quality systems, Regulatory Compliance, site licensing, stability programs, supplier qualification

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…

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14

Aug

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Site LicensingForeign Site Reference Number, GMP compliance, Health Canada Regulations, natural health products, NHP importing, NHP manufacturing, NHP packaging, NHP site licence application, regulatory compliance Canada, site licence Canada

NHP Site Licensing Made Simple for Canadian Market

In Canada, any business that manufactures, packages, labels, or imports natural health products (NHPs) must hold a valid site licence obtained from Health Canada. This licence confirms that the company complies with the requirements set out in the Natural Health Products Regulations and Site Licensing Guidance Document, including adherence to…

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