Product Details

Adverse Reactions, Quality SOP

PURPOSE: This procedure describes the process by which suspected adverse reactions are reviewed and evaluated to ensure they are reported to Health Canada in a timely manner.

This SOP complies to the Cannabis Regulations : Part 12, s.248

Includes the following documents:

1. QA.SOP-012: Investigating and Reporting Adverse Reactions

2. FORM.QA-012A: Suspected Adverse Reaction Form

3. FORM.QA-012B: Adverse Reaction Assessment Report

3. FORM.QA-012C: Adverse Reaction Register

QA.SOP-012 SOP SAMPLE QA.SOP-012 Investigating and Reporting Adverse Reactions (AVAILABLE AT PURCHASE) FORM.QA-012A Suspected Adverse Reaction Form (AVAILABLE AT PURCHASE) FORM.QA-012B Adverse Reaction Assessment Report (AVAILABLE AT PURCHASE) FORM.QA-012C Adverse Reaction Register (AVAILABLE AT PURCHASE)