First off, here is a direct link to Health Canada’s website outlining the upcoming regulation changes for the Natural Health Product sector - https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/guide-natural-health-products-0158.html. 

What Changed

• Clearer, end-to-end quality system expectations. Stronger emphasis on a documented QMS (‘Quality Management System’) - quality manual, roles, self-inspection, management engagement, and on the QAP’s explicit approval responsibilities. 
  
  
• Role-by-activity mapping. Clarifies which GMP sections apply to manufacturers, packagers, labellers, importers, distributors, and storers (e.g., specs, premises, equipment, QA, records). Depending on your business, the rules are different. 
  
  
• Testing modernization.
• Confirmatory testing encouraged for added assurance (esp. new or higher-risk suppliers).
  
  
• Reduced/rotational testing allowed with strict prerequisites (e.g., water activity, historical data, statistical confidence, ongoing controls) and clear OOS escalation rules.
  
  
• Composite testing generally not acceptable for finished products (risk of masking contaminants).
  
  
• Quantification by input permitted when controls and documentation meet defined criteria. 
  
  
• Importer accountability upgraded. Ability to leverage MRA/PIC/S evidence (e.g., batch certificates) with continued Canadian release responsibility and periodic batch record oversight. 
  
  
• Premises & utilities detail. Practical requirements for zoning, pest control, environmental monitoring, water quality, and documented storage conditions (including daily records). 
  
  
• Equipment & personnel. Explicit expectations for fit-for-purpose equipment, cleaning/calibration logs, and training matrices with periodic GMP refreshers and effectiveness checks. 
  
  
• Risk/CAPA appendices. Risk classification for observations and a structured CAPA process to standardize remediation. 
  
  

Why This Matters

• There is a firm deadline. By Mar 4, 2026, regulated parties must be able to provide evidence of compliance. Health Canada inspections will expect records, not intentions. 
  
  
• Reduced testing = reduced risk only if controlled. The guide lets you cut cost/time without cutting assurance, but only with robust data (side note, it’s MUCH easier to collect and demonstrate data using an electronic QMS), supplier qualification, and QAP governance. 
  
  
• Importing gets stricter. Leveraging foreign GMP is helpful, yet you remain responsible for Canadian release, label alignment, and periodic verification. 
  
  
• Data integrity moves center stage. Daily environment logs, water results, calibration, training, CAPA, and batch review must be consistent, retrievable, and audit-ready. When it comes to data integrity, following the ALCOA++ framework is mandatory.
  
  

ALCOA++

The full acronym ALCOA++ expands on the original ALCOA principles by adding completeness, consistency, enduring quality, and availability, as well as the most recent addition: traceability. 

1. Attributable: Data should be traceable to the person or system that generated it. 
2. Legible: Data must be in a readable and understandable form to allow for review. 
3. Contemporaneous: Data should be captured at the time the observation or activity occurs. 
4. Original: The data should be the first-hand capture of the observation, or a certified true copy. 
5. Accurate: The data must exactly reflect what was observed and recorded, with any changes or errors clearly documented. 
6. Complete: All data, including tests, reanalyses, and any missing information, should be recorded. 
7. Consistent: Data should be documented in a logical, orderly, and chronological sequence. 
8. Enduring: Records must be maintained in a permanent or semi-permanent form for the specified regulatory duration. 
9. Available: Data must be accessible for review, audits, and inspections throughout its entire lifecycle. 
10. Traceable: There should be a complete audit trail showing who changed what, when, and why. 

C15 eQMS Can Help

C15 eQMS gives you the controls, traceability, and evidence this guide expects, straight out of the box:

• Specifications control & QAP release (complete with 21 CFR Part 11 compliant signatures that fully adhere to ALCOA++ principles): versioned specs, change control, e-signatures, and a QAP dashboard for documented approvals and release decisions
  
  
• Testing strategy governance: workflows to design/justify reduced or rotational testing; automated COA analysis (to aggregate your test result data and do trend analysis), OOS handling, and seamless integration into digital batch records
  
  
• Importer toolkit: supplier qualification, COA ingestion, periodic batch record review reminders, and label control checks
  
  
• Equipment & training: calibration/Preventative Maintenance schedules, usage/cleaning logs, training matrices (full role-based curriculum training available) with read-and-understand and effectiveness checks, deviation handling
  
  
• CAPA & risk: built-in risk assessment for quality events and guided CAPA workflows aligned to the guide’s appendix.
  
  
• EXPERIENCE: C15 currently has 15+ customers operating in GMP production environments and our team of Customer Success Managers have a track record of success when it comes to assisting with audit preparation and validation of systems (another GMP requirement). 

Ready to hit GMP by March 2026?

Speak with our experts and book a quick walkthrough of the C15 eQMS platform and become audit-proof for 2026.