QA.SOP-012 Investigating and Reporting Adverse Reactions
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…
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QA.SOP-013 Surveillance of Adverse Reaction Reports
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…
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QA.SOP-014 Approval of Analytical Laboratories
PURPOSE: This procedure describes the assessment and approval process for laboratories providing analytical testing services. This SOP complies to the Cannabis Regulations : Part 5, s.92 Includes the following documents: 1. QA.SOP-014: Approval of Analytical Laboratories 2. FORM.QA-014A: Laboratory Assessment Questionnaire 2. FORM.QA-014B: Laboratory Qualification Report 2. FORM.QA-014C: Approved…
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