GMP compliance Canada

07 Oct 2025

Foreign Site Reference Number (FSRN) for Canada: A Complete Guide

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Please note that Health Canada officially ended the Foreign Site Reference Number (FSRN) process on February 16, 2026. The Department determined that the mechanism was no longer necessary and has consolidated the review of foreign site Good Manufacturing Practices (GMP) evidence within the existing site licensing pathway. Any new FSRN…

03 Jun 2025

Why a QAP for NHPs Is Essential for GMP Compliance in Canada

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In the Canadian natural health product (NHP) industry, Good Manufacturing Practices (GMP) are not only a regulatory requirement but also a fundamental part of ensuring consumer safety, product quality, and trust. At the heart of GMP compliance is the Quality Assurance Person for NHPs (QAP). This individual is critical in…

13 May 2025

How to Get a Drug Identification Number (DIN) in Canada — A Guide for Importers and Manufacturers

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Entering the Canadian pharmaceutical market requires more than just a good product—it requires regulatory approval. If you’re planning to sell prescription drugs, over-the-counter medications, medicated shampoos, or sunscreens in Canada, you’ll need a Drug Identification Number (DIN) issued by Health Canada. The DIN is not just a tracking number; it’s…

21 Apr 2025

GMP Regulations for Natural Health Products (NHPs) | Overview and Compliance in Canada

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What are GMPs for NHPs?Quality Assurance Person (QAP) in the GMP ContextWhy GMPs Matters for NHPs?GMP Requirements for Natural Health Products in CanadaCompliance with the Canadian NHP RegulationsEstablishing a Quality SystemRaw Material and Supplier ControlsManufacturing Process ControlsRecord-Keeping RequirementsInternal Audits and Ongoing ComplianceProduct Testing and StabilityComplaint Handling and Recall ManagementKey Principles…