What is GUI-0158?

GUI-0158 is the official guidance document that helps stakeholders understand and comply with the GMP requirements outlined in Part 3 of the Natural Health Products Regulations. It is a key reference for manufacturers, importers, and other parties to ensure the quality and safety of NHPs available to Canadian consumers. The new version replaces the previous guide, with a focus modernizing and clarifying the regulations to better align with current industry practices and international standards.

Key Changes:

The updated GUI-0158 is more than just a re-format; it introduces several new and clarified elements that businesses must be prepared to address.

1. A more user-friendly and comprehensive guide
2. Emphasis on Quality Risk Management
3. Clarified Roles and Responsibilities
4. Enhances focus on Data Integrity
5. Guidance on SOPs, GDP, and records for better clarity
6. Updated Risk Classification section
7. Provides additional guidance on CAPA plan, quality agreements, stability programs, mock recalls, GMP evidence, deviations and out-of-specifications (OOS), batch records and certificates of manufacture, reduced and rotational testing, and testing exemptions.

Preparing for the Transition:

The six-month transition period, from September 4, 2025, to March 4, 2026, is an opportunity for businesses to review and update their processes.

Our team can help you navigate these changes, ensuring your business remains compliant and ready for audits. Contact us today!  

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