Health Canada has opened a consultation to update its 2015 Good Manufacturing Practices (GMP) guide for Natural Health Products (NHPs). This effort is aimed at refining the existing guidelines, making them easier to understand and implement, while also introducing additional flexibility where needed. The proposed changes will have a direct impact on companies involved in the manufacturing, packaging, labeling, importing, distributing, and testing of NHPs. Here, we will outline the scope of the updates, the key changes being proposed, and how businesses can best prepare for the new guidelines.

Scope and Purpose

The draft updates aim to clarify regulatory expectations for NHP businesses and introduce more flexibility in applying GMP principles, without compromising product quality or safety. Health Canada’s goal is to create a document that not only helps companies comply with the regulations but also aligns more closely with the Government of Canada’s requirements for clear language, accessibility, and modern formatting.

This consultation is open until December 16, 2024, and stakeholders can provide feedback through an online questionnaire. Once the feedback is reviewed, Health Canada will publish the final version of the updated guide, followed by a transition and implementation period.

What Are the Changes?

The updated GMP guide contains several important revisions designed to improve both clarity and flexibility for NHP businesses:

1. Simplified Language and Structure: The guide is now clearer and easier to navigate, aligning with the Government of Canada’s mandate for plain language and accessibility. This change will reduce the complexity of the regulatory language, making it more user-friendly for manufacturers and other stakeholders.
2. Increased Flexibility: The revised guide introduces flexibility where it makes sense, especially for smaller or less complex NHP operations. For example, businesses may now be able to adapt certain quality system elements to their specific operations rather than strictly adhering to a one-size-fits-all model. This change is intended to reduce unnecessary burdens while maintaining rigorous safety and quality standards.
3. Alignment with Other Quality Systems: Health Canada has made efforts to better align the NHP GMP guide with broader quality management practices, such as those found in pharmaceutical regulations (though NHPs are not fully governed by these standards). This includes an emphasis on incorporating quality risk management (QRM) into NHP production. QRM is a systematic process used to identify, evaluate, and control risks throughout a product’s lifecycle. By adopting this approach, companies can ensure higher levels of safety and quality while improving operational efficiency.
4. Enhanced Emphasis on Quality Assurance: The new guide places significant focus on the role of Quality Assurance Personnel (QAP) and their responsibilities, ensuring that every batch of NHPs is reviewed and approved before entering the market. There’s also more emphasis on self-inspections and quality audits, helping companies continuously improve their processes.
5. Record-Keeping and Traceability: There’s a heightened focus on ensuring comprehensive records are maintained throughout the production process, from raw materials to the finished product. Companies will need to ensure their documentation aligns with the new guidelines to provide traceability and accountability in the event of a recall or quality issue.
6. Stability Testing: Stability periods, applicable to certain activities, are highlighted in the updated guide. Businesses must ensure that their NHPs remain within acceptable quality parameters throughout their intended shelf life, backed by proper stability testing.

How Can I Be Prepared?

Preparation is key to ensuring your business is ready to comply with the updated GMP guidelines. Here are steps NHP businesses should take:

1. Review Your Current Quality Systems: Evaluate whether your existing quality management system is equipped to meet the new requirements. If not, you may need to make adjustments to your processes, documentation, and quality assurance roles.
2. Implement Quality Risk Management (QRM): Begin adopting QRM principles into your operations. Proactively identifying and managing risks will not only help with compliance but also improve overall product quality and business resilience.
3. Engage Senior Management: The updated guide emphasizes that leadership plays a crucial role in ensuring GMP compliance. Make sure your senior management is actively involved in your quality systems and that they provide the necessary resources for compliance.
4. Train Your Staff: Ensure that all personnel, especially those involved in quality assurance, are fully trained and qualified to meet the new guidelines. Continuous education and training will be crucial to maintaining compliance over time.
5. Prepare for Self-Inspections: Develop a robust system for self-inspections and internal audits to regularly assess the effectiveness of your GMP processes. This will help identify potential areas for improvement before issues arise.
6. Update Record-Keeping Practices: Ensure that your documentation processes are aligned with the new requirements, particularly around batch records, testing, and quality assurance. Accurate record-keeping will be vital in maintaining traceability and meeting regulatory requirements.

Participate in the Consultation

Now is the time to have your say. The consultation on the draft updates is open until December 16, 2024. By participating, you can help shape the final GMP guide that will impact your business and the entire NHP industry. Submit your feedback through Health Canada’s online questionnaire and ensure your concerns and insights are heard.

Get Expert Advice

Navigating regulatory changes can be complex, but it’s crucial to remain compliant in a dynamic landscape. Partnering with experts who specialize in NHP regulations can provide the guidance you need to adapt quickly and efficiently. At dicentra, we help businesses comply with Health Canada’s evolving NHP regulations, including GMP and quality risk management. We can help you assess your current systems, develop new quality protocols, and ensure you’re fully prepared for the transition to the updated guidelines.

If you need assistance or have questions about how these changes will affect your business, feel free to reach out for a consultation.