Overview
All adult-use cannabis products and medical-use cannabis products must be processed in accordance with Good Manufacturing Practice (GMP) standards, as applicable for the type of cannabis or cannabis product being processed.
All licensees or registrants must maintain GMP standards in their processing facility operations for the duration of the license period. There are NO exceptions to the requirement to process cannabis in accordance with GMP requirements.
GMP Audit Requirements
Good Manufacturing Practice (GMP) is a quality control system for ensuring that products are consistently produced and controlled in accordance with current federal regulations 21 CFR Parts 111 or 117 established by the Food and Drug Administration (FDA).
Within one (1) year of commencing licensed/registered operations the licensee/registrant must submit proof of a qualified third-party GMP audit, of the licensee’s extraction and/or manufacturing processes, as applicable, to the satisfaction of the Office.
NOTE: Adult-Use Cannabis Type 3 processor licensees and microbusiness licensees may request a conditional exemption under certain conditions, such as limited processing activities related to packaging, labeling, and branding of specified products. Conditional exemptions apply exclusively to those specific product types and activities and are contingent upon submission of a conditional exemption request and written approval from the Office.
Resources
Guidance regarding GMP Audit Requirements and additional resources can be found here:
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GMP Guidance
This guidance is intended to provide Adult Use Cannabis licensees and Registered Organizations with an understanding of the requirements to process cannabis in accordance with Good Manufacturing Practices (GMP).
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Approved AU GMP Auditors
A list of auditors approved by the Office to conduct GMP audits of Adult-Use Cannabis Processor Licensees.
Download
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GMP Audit Conditional Exemption Application
This form is designed for Adult-Use Cannabis Type 3 processors and microbusinesses seeking a conditional exemption from the GMP audit under the specified circumstances.
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