QA.SOP-002: Good Documentation Practices (GDPs)
PURPOSE: This GACP-compliant SOP outlines the way in which data and observations in the cannabis industry are recorded, to ensure entries are legible, accurate, and traceable. This SOP complies to the Cannabis Regulations : Part 11 Includes the following documents: 1. QA.SOP-002: Good Documentation Practices 2. FORM.QA-002A: Employee Signature…
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QA.SOP-003: Managing Change Controls
PURPOSE: This GACP-compliant Change Control SOP describes how to request, assess, and approve changes at a cannabis facility, to ensure such changes are conducted in a controlled manner. This SOP complies to the Cannabis Regulations : Parts 5 and 11 Includes the following documents: 1. QA.SOP-003: Managing Change Controls…
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QA.SOP-004: Managing Deviations and CAPAs
PURPOSE: This procedure describes the process of identifying, evaluating, and resolving incidents that could negatively impact the quality or safety of a cannabis product, or cause a regulatory non-conformance. This SOP complies to the Cannabis Regulations : Part 5, s.88 Includes the following documents: 1. QA.SOP-004: Managing Deviations and…
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QA.SOP-005: Personnel Training Program
PURPOSE: This procedure describes the training program for facility personnel, which is designed to ensure that tasks are completed efficiently, consistently and in adherence with quality and regulatory standards. This SOP complies to the Cannabis Regulations : Parts 5 and 11 Includes the following documents: 1. QA.SOP-005: Personnel Training…
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QA.SOP-006: Managing Customer Complaints
PURPOSE: This procedure describes how to handle customer complaints as part of a commitment to protect public health and safety. This SOP complies to the Cannabis Regulations : Part 2, s.19 Includes the following documents: 1. QA.SOP-006: Managing Customer Complaints 2. FORM.QA-006A: Business Client Complaint Form 3. FORM.QA-006B: Retail…
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QA.SOP-007: Initiating and Simulating a Recall
PURPOSE: This procedure describes the steps for initiating a recall of cannabis product sold, distributed, or exported. This SOP must be conducted prior to launching an actual recall (in accordance with QA.SOP-008: Executing a Recall). This SOP complies to the Cannabis Regulations : Part 2, s.46; Part 12, s.247. …
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QA.SOP-008: Executing a Recall
PURPOSE: This Cannabis Recall SOP describes the steps required to execute a recall of cannabis products that were sold, distributed, or exported, in according with Part 2 – s.46 and 12 – s.247 of the Cannabis Regulations. This SOP complies to the Cannabis Regulations : Part 2, s.46; Part 12,…
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QA.SOP-009: Conducting Quality Risk Assessments
PURPOSE: This procedure describes the process for assessing risks related to personnel health and safety, and to the quality of cannabis products. This SOP complies to the Cannabis Regulations : Part 5, s.88.93 Includes the following documents: 1. QA.SOP-009: Conducting Quality Risk Assessments 2. APPENDIX.QA-009: Risk Analysis and Management…
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QA.SOP-010: Conducting Internal Audits
PURPOSE: This Cannabis Internal Audit SOP describes the process for conducting internal audits to ensure that the quality system in place is effective and complies with Health Canada regulatory requirements. This SOP complies to GPP and GACP Standards. Includes the following documents: 1. QA.SOP-010: Conducting Internal Audits 2. FORM.QA-010A:…
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QA.SOP-011 Conducting Product Quality Reviews (PQRs)
PURPOSE: This procedure describes the steps for verifying the quality of final cannabis products over time. This is accomplished by evaluating product and process consistencies, identifying trends (including process gaps), and assessing the suitability of current specifications. This SOP complies to GPP and GACP Standards. Includes the following documents:…
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