CA Cannabis Regulations Review of Manufacturing and Track and Trace Requirements

Transcription

1 CA Cannabis Regulations Review of Manufacturing and Track and Trace Requirements Executive Summary InstantGMP, Inc. provides a complete solution for manufacturing products that comply with Good Manufacturing Practices. InstantGMP MES Track & Trace is a manufacturing execution software with modules for inventory management, electronic batch records, specification management, equipment control and document management. Our Standard Operating Procedures provide the basis to fulfil regulatory requirements for a Quality System. Our implementation program provides training for all users of the software and ensures the software is properly applied in optimizing manufacturing and warehouse operations. We have reviewed the sections of the California code for regulations for manufacturing cannabis that will become effective January 1, This review was done to determine if employing the InstantGMP solution can help a cannabis manufacturer become compliant. Our review suggests that the InstantGMP software, SOPs and implementation can bring a cannabis product company 95% of the way to compliance with the manufacturing, packaging, labeling, and the track and trace requirements of the new regulations. The manufacturer can then use InstantGMP, Inc. s consulting and customization services to become 100% compliant. The specific activities needed to close the gap are detailed in this report.

2 California Code of Regulations, Title 17 Division 1 Chapter 13. Manufactured Cannabis Safety SUBCHAPTER 1. General Provisions and Definitions Article 3. Good Manufacturing Practices Requirements for Personnel Grounds Facility Construction and Design Sanitary Operations Sanitary Facilities and Controls Equipment and Utensils Article 4. Production and Process Controls General Provisions

3 Quality of Raw Materials and Ingredients InstantGMP software provides for compliance with the documentation requirements. InstantGMP also provides Standard Operating Procedures that mostly comply with the make the SOP Manufacturing Operations InstantGMP software provides for compliance with the documentation requirements. InstantGMP also provides Standard Operating Procedures that mostly comply with the make the SOP Hazard Analysis InstantGMP does not provide Standard Operating Procedure for hazard analysis, but can provide one upon request Preventive Controls InstantGMP software provides for compliance with the documentation requirements. InstantGMP also provides Standard Operating Procedures that mostly comply with the make the SOP Equipment and Machinery Qualification InstantGMP provides equipment management and control functions that meet the requirements of this section. InstantGMP also provides Standard Operating Procedures that mostly comply with the requirements. Some wording specific to cannabis manufacturing can be added to be Master Manufacturing Protocol InstantGMP provides the functions that meet the requirements of this section. InstantGMP also provides Standard Operating Procedures that mostly comply with the requirements. Some wording specific to cannabis manufacturing can be added to be Batch Production Record InstantGMP provides the functions that meet the requirements of this section. InstantGMP also provides Standard Operating Procedures that mostly comply with the requirements. Some wording specific to cannabis manufacturing can be added to be Product Complaints

4 Recalls Article 5. Special Processing Requirements Juice Processing InstantGMP does not have a Standard Operating Procedure for juice processing. One can be written upon request Dried Meat Processing InstantGMP does not have a Standard Operating Procedure for dried meat processing. One can be written upon request. Article 6. Other Responsibilities Standard Operating Procedures Weights and Measures InstantGMP does not have a Standard Operating Procedure for weights and measures. One can be written upon request Training Program Inventory Control Cannabis and Cannabis Products InstantGMP provides inventory control functions in its software that complies with the with the Waste Management InstantGMP provides inventory control functions in its software that complies with the with the

5 SUBCHAPTER 5. LABELING AND PACKAGING REQUIREMENTS Release to Distributor as Finished Product InstantGMP provides finished product control functions in its software that complies with the with the Article 2. Labeling Requirements InstantGMP provides for label control functions in its software that complies with the with the Article 3. Packaging InstantGMP provides for packaging control functions in its software that complies with the with the Article 2. Track-and-Trace System Track-and-Trace System General Requirements InstantGMP provides for complies with all general requirements Track-and-Trace System Loss of Access A Standard Operating Procedure can be written that will provide the required forms for managing a loss of access. CALIFORNIA CODE OF REGULATIONS TITLE 16 DIVISION 42. BUREAU OF CANNABIS CONTROL Article 6. Track and Trace Requirements Track and Trace Requirements InstantGMP complies with all requirements with the following exceptions: (f) A licensee shall monitor all compliance notifications from the track and trace system, and timely resolve the issues detailed in the compliance notification. (1) A licensee shall keep a record, independent of the track and trace system, of all compliance notifications received from the track and trace system, and how and when compliance was achieved. The software can be customized to provide compliance notifications through alerts Track and Trace Reporting InstantGMP complies with all requirements with the following exceptions:

6 (A) The licensee shall transport pursuant to a shipping manifest generated through the track and trace system. The software can be customized to provide shipping manifests that comply with this requirement Loss of Access A Standard Operating Procedure can be written that will provide the required forms for managing a loss of access Track and Trace System Reconciliation InstantGMP manages reconciliation through its inventory functions Storage-Only Services InstantGMP can manage storage-only services through its inventory management system Storage of Batches for Testing InstantGMP can manage storage through its inventory management system Packaging and Labeling InstantGMP provides for compliance with these requirements Testing Sample InstantGMP provides for compliance with these requirements including storage of videos Laboratory Testing Results InstantGMP provides for compliance with these requirements including management of specifications Quality-Assurance Review InstantGMP provides for compliance with these requirements Inventory Reconciliation InstantGMP provides for compliance with these requirements Records InstantGMP provides for compliance with these requirements with the following exception. (9) Records relating to tax payments collected and paid under Sections and of the Revenue and Tax Code. The software can be customized to provide a function to record tax payments Shipping Manifest InstantGMP provides for collection the required information, but does not have a shipping manifest function. The software can be customized to provide the required manifest with an automatic notification to the Bureau.