Compliance and Enforcement Policy for Good Manufacturing Practices – Health Canada Overview

Policy Purpose and Scope

The Compliance and Enforcement Policy (POL-0001) establishes Health Canada’s framework for promoting and verifying compliance with Good Manufacturing Practices (GMP) under the Food and Drugs Act and associated regulations. It applies to regulated parties involved in the manufacture, importation, distribution, and testing of drugs (including active pharmaceutical ingredients – APIs), natural health products, and Class II–IV medical devices. The policy emphasizes a risk-based, consistent, and transparent approach to compliance activities and enforcement. Compliance and Enforcement Policy (POL-0001) - Canada.ca

Core Principles

• Risk-Based Approach: Compliance and enforcement activities are prioritized based on the potential risk to health (e.g., product type, therapeutic class, history of non-compliance).
• Consistency and Transparency: Actions are applied fairly, predictably, and with clear communication of expectations and outcomes.
• Proportionality: Enforcement responses are proportionate to the nature, severity, and impact of non-compliance.
• Voluntary Compliance: Emphasis on education, guidance, and encouragement of self-correction before escalating to formal enforcement.

Compliance Promotion Activities

Health Canada promotes compliance through:

• Publication of GMP guidance documents and interpretation policies.
• Pre- and post-inspection education sessions.
• Stakeholder consultations and outreach.
• Voluntary corrective action plans encouraged before formal enforcement.

Compliance Verification

Primary tools include:

• Routine and for-cause GMP inspections of domestic and foreign sites.
• Document reviews and quality system assessments.
• Reliance on recognized foreign regulatory authorities (e.g., via Mutual Recognition Agreements) for foreign site inspections where appropriate.

Inspection observations are classified by risk level, with critical observations requiring immediate action.

Enforcement Actions

When non-compliance is identified, Health Canada may apply a range of measures in escalating order:

• Letter of Non-Compliance or Notice of Non-Compliance: Formal notification requiring corrective action.
• Administrative Monetary Penalties (AMPs): Financial penalties for certain violations.
• Compliance Orders or Injunctions: Court-ordered cessation of activities.
• Product Seizure, Detention, or Recall: To prevent distribution of non-compliant products.
• Licence Suspension or Cancellation: For serious or repeated non-compliance.
• Prosecution: Criminal proceedings for egregious violations.

The choice of action considers risk to health, compliance history, intent, and effectiveness of voluntary correction.

Practical Implications for Regulated Parties

• Maintain robust GMP systems and documentation to facilitate inspections.
• Respond promptly and comprehensively to inspection observations.
• Implement effective corrective and preventive actions (CAPA) to address deficiencies.
• Monitor Health Canada enforcement trends and policy updates.

This policy supports public health protection by ensuring consistent, fair, and effective oversight of GMP compliance across the regulated sectors. Full details, including risk classification criteria, enforcement escalation ladder, and references to specific regulations, are provided in the official POL-0001 document on the Health Canada website. Compliance and Enforcement Policy (POL-0001) - Canada.ca