Cannabis Manufacturing Program

Service Description:

1. Assessment of the project
2. Review of requirements and standards
3. Customization/Drafting/Initial gathering of info and document creation
3.1 Manufactured Cannabis Safety
3.1.1 Definitions
3.1.1.1 Applicability
3.1.1.2 Owners and Financial Interest Holders
3.1.1.3 Premises Diagram
3.1.2 General Provisions
3.1.2.1 License Required
3.1.2.2 Personnel Prohibited from Holding Licenses
3.1.2.3 Manufacturing License Types
3.1.2.4 Additional Activities
3.2 Manufacturing Licenses
3.2.1 Applications for Licensure
3.2.1.1 Temporary Licenses.
3.2.1.2 Annual License Application Requirements.
3.2.1.3 Annual License Application Requirements – Business Information
3.2.1.4 Annual License Application Requirements – Owners.
3.2.1.5 Annual License Application Requirements – Manufacturing Premises and Operations
Information.
3.2.1.6 Annual License Application Requirements – Compliance with CEQA
3.2.1.7 Limited Waiver of Sovereign Community
3.2.1.8 Incomplete and Abandoned Applications
3.2.1.9 Application Withdrawal
3.2.2. Fees
3.2.2.1 Application and License Fees
3.2.2.2 Gross Annual Revenue Calculation
3.2.3 Approval or Denial of Applications
3.2.3.1 New License Approval
3.2.3.2 Denial of License
3.2.3.3 Substantially Related Acts
3.2.3.4 Criteria for Evidence of Rehabilitation
3.2.3.5 Appeal of License Denial
3.2.4 Licensing
3.2.4.1 License Constraints
3.2.4.2 Change in Licensed Operations
3.2.4.3 Add or Remove Owner(s) and Financial Interest Holders
3.2.4.4 Death, Incapacity, or Insolvency of a Licensee
3.2.4.5 License Renewal
3.2.4.6 Disaster Relief
3.2.4.7 Notification of Criminal Acts, Civil Judgments, and Revocation of a Local License, Permit, or
Other Authorization after Licensure
3.2.4.8 Licensee Authorization to Release Data to Financial Institutions
3.2.4.9 Financial Institution Request for Licensee Information
3.2.5 Shared-Use Facilities
3.2.5.1 Definitions
3.2.5.2 Type S License
3.2.5.3 Registration to Operate a Shared-Use Facility
3.2.5.4 Shared-Use Facility Conditions for Operation
3.2.5.5 Shared-Use Facility Compliance Requirements
3.3 Requirements of Operation for Manufacturer Licensees
3.3.1 Safety and Security
3.3.1.1 Security Plan
3.3.1.2 Video Surveillance
3.3.1.3 Notification of Theft, Loss, or Diversion
3.3.2 Extractions
3.3.2.1 Permissible Extractions.
3.3.2.2 Volatile Solvent Extractions
3.3.2.3 Ethanol Extractions
3.3.2.4 Closed-Loop Extraction System Requirements
3.3.3 Good Manufacturing Practices
3.3.3.1 Manufacturing Practices Definitions
3.3.3.2 Quality Control Program
3.3.3.3 Grounds, Building, and Manufacturing Premises
3.3.3.4 Equipment and Utensils
3.3.3.5 Personnel
3.3.3.6 Cannabis Product Components
3.3.3.7 Manufacturing Processes and Procedures
3.3.3.8 Product Quality Plan
3.3.3.9 Master Manufacturing Protocol
3.3.3.10 Batch Production Record
3.3.4 Special Processing Requirements
3.3.4.1 Juice Processing
3.3.4.2 Dried Meat Processing
3.3.5 Other Responsibilities
3.3.5.1 Standard Operating Procedures
3.3.5.2 Weights and Measures
3.3.5.3 Training Program
3.3.5.4 Inventory Control – Cannabis and Cannabis Products
3.3.5.5 Waste Management
3.3.5.6 Consent to Sample Collection
3.3.5.7 Product Complaints
3.3.5.8 Recalls
3.4 Products
3.4.1 Cannabis Product Standards
3.4.1.1 Prohibited Products
3.4.1.2 Requirements for Edible Cannabis Products
3.4.1.3 Requirements for Topical Cannabis Products, Concentrates, and Other Cannabis Products
3.4.1.4 Orally-Consumed Products Containing Alcohol
3.4.2 Cannabinoid Concentration Limits
3.4.2.1 THC Concentration Limits.
3.4.3 Failed Product Batches
3.5 Labeling ad Packaging Requirements
3.5.1 General Provisions
3.5.1.1 Applicability
3.5.1.2 Release to Distributor as Finished Product
3.5.2 Labeling Requirements
3.5.2.1 General Provisions
3.5.2.2 Labeling Requirements: Pre-Rolls and Packaged Flower
3.5.2.3 Primary Panel Labeling Requirements: Manufactured Products
3.5.2.4 Additional Primary Panel Labeling Requirements: Edible Products
3.5.2.5 Informational Panel Labeling Requirements
3.5.2.6 Cannabinoid Content Labeling
3.5.2.7 Labeling Restrictions
3.5.2.8 Statement of Characteristic Anticipated Effects
3.5.2.9 Universal Symbol
3.5.3 Packaging
3.5.3.1 Packaging
3.5.3.2 Child-Resistant Packaging Requirements
3.6 Compliance Applicable to Manufacturing Licensees
3.6.1 Records
3.6.1.1 Record Keeping Requirements
3.6.1.2 Sales Invoices and Receipts
3.6.2 Track-and-Trace System
3.6.2.1 Track-and-Trace System General Requirements
3.6.2.2 Track-and-Trace System Reporting Requirements
3.6.2.3 Track-and-Trace System – Loss of Access
3.6.2.4 Track-and-Trace System – Temporary Licenses
3.6.2.5 Track-and-Trace System – UID Tag Order
3.6.3 Advertising and Marketing
3.6.4 Inspections
3.6.4.1 Inspections
3.6.4.2 Notice to Comply
3.6.5 Suspensions and Revocations of a License
3.6.5.1 Emergency Decision and Order
4. Final Review and Completion

Requirements:

– Send approved company logo and your facility address to be
incorporated on the documents, if applicable, to
services@consultareinc.com.
– Google Meet – Screen Share for discussion. To be scheduled by our
Compliance Team, if applicable.
– Program(s), Policy (or Policies), Procedure(s), and Form(s)
purchased require customization, review, and approval for their
intended use.
-Recommendation and guidance given or implied are based on best
practices and the adherence to a regulatory or certification body
requirements and may or may not conform to the requirements or
the intended use or application.
– Consult your inhouse Practitioner, Preventive Control Qualified
Individual (PCQI) or Qualified Individuals (QI) prior to the
implementation of the Program(s), Policy (or Policies), Procedure(s),
and Form(s).
– Program(s), Policy (or Policies), Procedure(s), and Form(s) created
requires review and approval by your company’s authorized
personnel and qualified personnel.

Deliverables:

– Program, Applicable Forms, and Services described on the service description.

Delivery Date:

– 108 Days / 432 to 648 Hours (Approximate)