Product Details

Adverse Reactions, Quality SOP, Surveillance

PURPOSE: This procedure describes the adverse reaction monitoring program and defines the process by which adverse reaction summary reports are created and submitted to authorities. It thus services to increase cumulative knowledge about product safety based on actual use.

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

Includes the following documents:

1. QA.SOP-013: Surveillance of Adverse Reaction Reports

2. FORM.QA-013A: Annual Summary Report of Adverse Reactions

QA.SOP-013 SOP SAMPLE QA.SOP-013 Surveillance of Adverse Reaction Reports (AVAILABLE AT PURCHASE) FORM.QA-013A Annual Summary Report of Adverse Reactions (AVAILABLE AT PURCHASE)