Table of Contents:
Safe and Accurate Packaging and Labeling (Measure 1) 3
Product Safety Fundamentals Summary 3
Design and Maintenance of Adequate Facilities 3
Control of Raw Materials, Solvents, Impurities, and Pesticides 4
Documented Manufacturing Processes & In-process Testing 4
Controlled Storage Conditions 5
Environmental Sampling & Testing 5
Self Inspection 6
Record Keeping 7
Packaging 7
Registration 7
Packaging Assurances 8
Labeling 9
Label Inclusions 9
Label Exclusions 10
Warnings Statements 12
Process Controls 13
Repackaging/Relabeling 13
Testing Plan – 35pts (Measure 2) 14
Overview 14
Facilitation of Sample Testing 16
Quality Assurance Review (QAR) – After Lab Approval 20
Internal Product Sampling and Testing 23
Remediation 24
Recall Plan – 25 pts (Measure 3) 26
Adverse Event Planning 27
Adverse Event Investigation and Recall 29
Recall Investigation Steps 30
Investigation SOP 34
Adverse Event Documentation and Record Keeping 34
Destruction and Disposal of Cannabis Products 35
Notice to the Department 35
Method of Destruction 35
Cannabis Waste Disposal 36
Appendix 1A – Master Batch Record 1: Preparation 38
Appendix 1B – Master Batch Record 2: Processing 39
Appendix 1C – Master Batch Record 3: Packaging/Labelling 40
Appendix 1D – Master Batch Record 4: Testing/QA 41
Appendix 2 – Batch Label 42
Appendix 3 – Record of Label Modification 43
Appendix 4 – Quality Assurance Review Checklist 44
Appendix 5 – Adverse Event Team Contact List 47
Appendix 6 – Adverse Event Investigation/Complaint Form 48
Appendix 7 – Health Hazard Evaluation Form 49
Appendix 8 – Recall Checklist 51
Appendix 9 – Recall Communications Log 52
Appendix 10 – Recall Recovery Summary 53
Cannabis Product Safety and Labeling is a cornerstone document for any legal cannabis business, whether for cultivation or extraction and infusion. This Plan is customized to match up with the requirements of the State of Illinois and addressed each of their Measures listed in Exhibit E (above).
We have used text that cross references the IL cannabis regulations and application requirements with what we’ve found in other state regulations as well as Canadian and European regulations and the pharmaceutical industry.
The first goal of the document is to help make it easy for you to obtain a craft grower license for the cultivation of cannabis in Illinois, but the longer-term goal is to help you establish accurate and well documented procedures for the purity, labeling and tracking of your cannabis products.
Table of Contents Coming Soon!
